MD Orthopaedics MITCHELL PONSETI AFO User manual

Instructions for Use
MITCHELL PONSETI® Ankle Foot Orthosis (AFO)
PONSETI®Abduction Bar
MITCHELL PONSETI® Move Bar
MD Orthopaedics, Inc.
604 North Parkway Street
Wayland, IA 52654 USA
www.mdorthopaedics.com
Document MD-124.2
Version 9
April 2023
Emergo Europe B.V.
Westervoortsedijk 60
6827 AT Arnhem
The Netherlands
MedEnvoy
Prinses Margrietplantsoen 33
Suite 123
2595 AM The Hague
The Netherlands EN

Table of Contents
DISCLAIMER.......................................................................................................................................................................................................................................1
TRADEMARKS ...................................................................................................................................................................................................................................1
1 PREFACE ......................................................................................................................................................................................................................................1
1.1 Intended Purpose........................................................................................................................................................................................................1
1.2 Target Patient Group and Intended Users.......................................................................................................................................................2
1.3 Clinical Benets ............................................................................................................................................................................................................2
1.4 Explanation of Safety Warnings ...........................................................................................................................................................................2
1.5 Retention Instructions & Warranty......................................................................................................................................................................2
1.5.1 Technical Life Span........................................................................................................................................................................................2
1.5.2 Returns/Refunds.............................................................................................................................................................................................3
1.6 Obtaining Documentation and Information..................................................................................................................................................3
1.6.1 Ordering Documentation...........................................................................................................................................................................3
1.6.2 Other languages.............................................................................................................................................................................................3
1.6.3 Documentation Feedback..........................................................................................................................................................................3
1.6.4 Support and service......................................................................................................................................................................................3
2 DESCRIPTION OF THE PRODUCT .....................................................................................................................................................................................3
3 Clubfoot Treatment Overview.........................................................................................................................................................................................5
3.1 MITCHELL PONSETI® Ankle Foot Orthotic .......................................................................................................................................................6
3.2 MITCHELL PONSETI® AFO.........................................................................................................................................................................................7
3.3 PONSETI® Abduction Bar .........................................................................................................................................................................................8
3.4 Mitchell Ponseti® Move Bar.................................................................................................................................................................................. 11
4 SAFETY INSTRUCTIONS .................................................................................................................................................................................................... 13
4.1 Safe Disposal............................................................................................................................................................................................................... 14
4.2 Potential Health Consequences......................................................................................................................................................................... 14
5 STORAGE AND TRANSPORT............................................................................................................................................................................................ 14
5.1 How to Transport and Store the Product....................................................................................................................................................... 14
6 MAINTENANCE...................................................................................................................................................................................................................... 14
6.1 Reusing the Device .................................................................................................................................................................................................. 14
6.1.1 Cleaning the device.................................................................................................................................................................................... 14
6.2 How to Inspect the Product ................................................................................................................................................................................. 14
7 TROUBLESHOOTING .......................................................................................................................................................................................................... 15
7.1 How to Identify and Solve Problems............................................................................................................................................................... 15
7.2 Frequently Asked Questions............................................................................................................................................................................... 15
8 GLOSSARY ............................................................................................................................................................................................................................... 16
9 SYMBOL LEGEND ................................................................................................................................................................................................................. 17

1Document MD-124.2
DISCLAIMER
MD Orthopaedics makes no representations or warranties with respect to this manual and, to the maximum extent permitted by law,
expressly limits its liability for breach of any warranty that may be implied to the replacement of this manual with another. Furthermore,
MD Orthopaedics reserves the right to revise this publication at any time without incurring an obligation to notify any person of the
revision.
As the designer and manufacturer of products, MD Orthopaedics does not provide medical treatment and/or advice. Information
about the risks and benets of medical treatment, including treatment that involves the use of MD Orthopaedics products and
available alternatives is provided solely by physicians or other healthcare providers. If you have questions about your child’s treatment,
itisimportant to discuss those questions with the appropriate healthcare provider.
MD Orthopaedics does not, and cannot, warrant certain results from the use of its products.
The information provided in this documentation contains general descriptions and/or technical characteristics of the performance of
the products contained herein. This documentation is not intended as a substitute for and is not to be used for determining suitability
or reliability of these products for specic user applications. It is the duty of any such user to perform the appropriate and complete risk
analysis, evaluation, and testing of the products with respect to the relevant specic application or use thereof. Neither MD Orthopaedics
nor any of its aliates or subsidiaries shall be responsible or liable for misuse of the information that is contained herein. If you have any
suggestions for improvements or amendments or have found errors in this publication, please notify us.
All pertinent state, regional, and local safety regulations must be observed when using this product. For reasons of safety and to help
ensure compliance with documented system data, only the manufacturer shall perform repairs to components.
When devices are used for applications with technical safety requirements, the relevant instructions must be followed. Failure to observe
this information can result in injury or equipment damage.
MD Orthopaedics has made every eort to prevent that the labelling, instructions for use, making available, putting into service and
advertising of devices uses text, names, trademarks, pictures and gurative or other signs that may mislead the user or the patient
regarding the device’s intended purpose, safety, and performance.
Copyright © 2023 by MD Orthopaedics, Inc.
All rights reserved. No part of this publication may be reproduced, distributed, or transmitted in any form or by any means, including
photocopying, recording, or other electronic or mechanical methods, without the prior written permission of the publisher. For permission
requests, write to the publisher at the address below.
MD Orthopaedics, Inc.
604 North Parkway Street
Wayland, IA 52654
USA
1-877-766-7384
www.mdorthopaedics.com
TRADEMARKS
Mitchell Ponseti® and Ponseti® are registered trademarks of MD Orthopaedics.
MD Orthopaedics has made every eort to supply trademark information about company names, products and services mentioned in
this manual. Trademarks shown below were derived from various sources. All trademarks are the property of their respective owners.
General Notice: Some product names used in this manual are used for identication purposes only and may be trademarks of their
respective companies.
1 PREFACE
1.1 Intended Purpose
The MITCHELL PONSETI® Ankle Foot Orthosis (AFO) with the PONSETI® Abduction Bar or the MITCHELL PONSETI® Move Bar is
known as MITCHELL PONSETI® Brace, intended for use in the Ponseti method of treatment for the correction of Congenital Talipes
Equinovarus (CTEV) in infants and children less than or equal to eight years of age.The brace is intended to prevent relapse (equinus and
varus deformity of the heel).
The MITCHELL PONSETI® Brace is to be prescribed by a physician or healthcare provider trained in the Ponseti Method of clubfoot
treatment and is typically worn for 23 hours a day for three months after casting and then during night-time and nap time for 4-5 years
or until the physician or healthcare provider indicate the device is no longer needed.
A clinical orthotist, also trained in the Ponseti method, may assist the physician or healthcare provider in determining the correct size
ofthe AFO for the child. The orthotist may also train the child’s parents and families in the right way to put the AFO onto the child’s foot,
what cues may indicate poor t or other issues, and how to determine it is time to move to the next size.
Other members of the clinical team trained in the Ponseti method – nurses, physician assistants, or other licensed healthcare
professionals – may also train parents on the proper use of the MITCHELL PONSETI® Brace and make any necessary adjustments in t
or sizing.

2Document MD-124.2
The child’s parents or family or other designated caretaker are responsible for adhering to the prescribed Ponseti method treatment
regimen of 23 hours a day for three months, then during sleep and during naptime for the next 4-5 years or until the physician indicates
the device is no longer needed.
1.2 Target Patient Group and Intended Users
The MD Orthopaedics MITCHELL PONSETI® Ankle Foot Orthosis (AFO) with the PONSETI® Abduction Bar or MITCHELL PONSETI®
Move Bar is designed to be worn by a child (≤8) years of age with clubfoot after the casting portion of treatment is complete.
This document is intended for the physician, orthotist, clinical team, parents, and families of children receiving treatment with the
MITCHELL PONSETI® Ankle Foot Orthosis (AFO) with the PONSETI® Abduction Bar or MITCHELL PONSETI® Move Bar.
1.3 Clinical Benets
The MD Orthopaedics MITCHELL PONSETI® Brace (that includes the MITCHELL PONSETI® Ankle Foot Orthosis (AFO) and either the
PONSETI® Abduction Bar or the MITCHELL PONSETI® Move Bar) retains the position of the anatomically corrected clubfoot deformity
for up to 4-5 years following successful manipulation and casting as described by Dr. Ignacio Ponseti (the Ponseti Method), with a
relatively low risk of relapse/recurrence and/or surgical intervention.
1.4 Explanation of Safety Warnings
Caution indicates a hazard with a low level of risk which, if not avoided, could result in minor or moderate injury.
Indicates information considered important, but not hazard-related.
1.5 Retention Instructions & Warranty
Read and understand this manual and its safety instructions before using this product. Failure to do so can result in injury.
The product shall only be used by persons who have fully read and understand the contents of this user manual.
Ensure that each person who uses the product has read these warnings and instructions and follows them.
The manufacturer is not liable for cases of material damage or personal injury caused by incorrect handling or non-compliance with the
safety instructions. In such cases, the warranty will be voided. Warranty of the Mitchell Ponseti® Brace is one year under normal use,
andissingle patient multiple use. Normal use is dened by Normal Daily Use for 365 days/year.
This policy/warranty is non-transferable and covers normal wear and tear only. Altering the product and after-market modications
willvoid the warranty. Please contact us if you experience problems not outlined in this policy. Atypical matters will be handled on acase-
by-case basis.
1.5.1 Technical Life Span
On average, each AFO will last 3-9 months, depending on the child’s growth rate. As the child’s growth rate slows, more time can be
expected.
The bars are adjustable and may last more than one pair of AFOs. The bar width should be periodically checked and adjusted to match
the child’s shoulder width or as recommended by your physician, orthotist or healthcare provider.

3Document MD-124.2
1.5.2 Returns/Refunds
If the merchandise you received is defective or not as you ordered, please contact customer service or your point of purchase for quick
resolution.
For information on returning product and refunds, please contact
MD Orthopaedics, Inc.
604 North Parkway Street
Wayland, IA 52654
USA
www.mdorthopaedics.com
1-877-766-7384 or e-mail
[email protected]
No refunds or exchanges will be issued for Custom Color AFOs; all sales are nal.
1.6 Obtaining Documentation and Information
1.6.1 Ordering Documentation
Additional documentation, user instructions and technical information can be ordered by calling MD Orthopaedics at 1-877-766-7384 or
e-mailing [e-mail].
1.6.2 Other languages
Instructions for Use (IFU) manuals are available in other languages at www.mdorthopaedicsifu.com (Regulation (EU) 207/2012).
1.6.3 Documentation Feedback
If you are reading MD Orthopaedics’product documentation on the internet, any comments can be submitted at www.mdorthopaedics.com
(Regulation (EU) 207/2012) or comments can also be sent to [e-mail]. We appreciate your comments.
1.6.4 Support and service
For questions, information, technical assistance or to order user instructions, please contact:
MD Orthopaedics, Inc.
604 North Parkway Street
Wayland, IA 52654
USA
www.mdorthopaedics.com
1-877-766-7384 or e-mail [e-mail]
2 DESCRIPTION OF THE PRODUCT
The MITCHELL PONSETI® Brace is a Class I medical device intended for use only on children whose clubfoot is being corrected with the
Ponseti Method of treatment, and only as prescribed by a physician or healthcare provider fully trained in the Ponseti Method.
Preemie Bar: Size P6-0 or P5-0 AFOs are permanently attached to a Preemie Bar, which is pre-set to 10° dorsiexion and 60° abduction.
The bar adjusts in width from 15.0-20.0 cm, in 1-cm increments. The Preemie Bar can be cut down as small as 10 cm, upon request.
The MITCHELL PONSETI® Ankle Foot Orthosis shall be used with the following original accessories and components only:
• PONSETI® Adjustable Bar: Adjustable bar that easily clips on the AFO with the quick clip system.
oAvailable with either 10 or 15 degrees of dorsiexion
oAvailable in Extra Short, Short, and Long
• MITCHELL PONSETI® Move Bar: A dynamic bar that allows exion and extension of each leg while maintaining external rotation
of the feet.
oAvailable with either 10 or 15 degrees of dorsiexion
oAvailable in Short, Medium, and Long
• Pressure Saddle: This soft, comfortable pressure saddle attaches to the middle strap of the MITCHELL PONSETI® AFO to provide
additional relief of pressure areas.
oAvailable in size small and large. Size small is recommended for use with AFO Size 0000-1; Size large is recommended for use with
Size 2-12.
• MITCHELL PONSETI® Socks are a single layer sock designed to be used with AFOs using a soft, natural antibacterial, moisture wicking
bamboo material that have silicone grips and a high-visibility heel.
oAvailable in sizes 0 through 12.
• Bar Cover: This soft bar cover provides protection and comfort for your child, and is available in size small (5") and large (8"), in pink,
light blue, or dark blue.

4Document MD-124.2
The MITCHELL PONSETI® Ankle Foot Orthosis is available in four styles:
The MITCHELL PONSETI® Standard AFO uses the Ponseti Method of clubfoot correction. Our patented system features a soft lining for
comfort and compliance, soft synthetic leather straps. The location of the heel can easily be seen through two viewing holes in the back of
the AFO. The AFO is worn attached to the PONSETI® Abduction Bar or MITCHELL PONSETI® Move Bar in accordance with the standard
Ponseti bracing protocol. Available in sizes preemie through 12.
The MITCHELL PONSETI® Plantar Flexion Stop AFO limits plantar exion with rigid dorsiexion tomaintain the prescribed position of the
foot. Recommended for the complex clubfoot. This device is also good for children withhyperexible feet as it ensures the foot is always
held in a neutral or dorsiexed position. The AFO is worn attached tothePONSETI®Abduction Bar or MITCHELL PONSETI® Move Bar
in accordance with the standard Ponseti bracing protocol. Available in sizes 00 through 12. The MITCHELL PONSETI® Move Bar is
compatible with sizes 00 through 5.
The MITCHELL PONSETI® Toe Stilt AFO was specically designed by recommendation of Dr. Ponseti to maintain clinically desirable
dorsiexion by stretching the Achilles tendon and helping to keep the foot exible. This is achieved by the placement of a built in
wedge attached to the front of the AFO which keeps both feet in a dorsiexed position of 10 degrees when standing. The AFO is worn
attached to the PONSETI® Abduction Bar or MITCHELL PONSETI® Move Bar in accordance with the standard Ponseti bracing protocol.
The patient must be able to stand independently for the Toe Stilt AFO to have any eect when used without the PONSETI® Abduction Bar
or MITCHELL PONSETI® Move Bar. Available in sizes 2 through 11.
The MITCHELL PONSETI® Plantar Flexion Stop/Toe Stilt is a dual purpose AFO that supports the Ponseti Method of treating clubfoot.
The AFO is worn attached to the PONSETI® Abduction Bar or MITCHELL PONSETI® Move Bar in accordance with the standard
Ponsetibracing protocol. The Plantar Flexion Stop (PFS) is designed to structurally limit any plantar exion and work particularly well
in clubfoot cases with hypermobile or corrected atypical/complex deformity. The PFS is mounted on the standard AFO during the
assembly process but is designed to be custom t as necessary by the orthotist to meet the dynamic needs of each clubfoot child.
TheToeStilt encourages lower calf, Achilles tendon and plantar fascia stretch in the toddler who can stand independently without the
PONSETI® Abduction Bar or MITCHELL PONSETI® Move Bar. The Toe Stilt holds both feet at 10 degrees dorsiexion when standing.
Available in sizes 2 through 11. The MITCHELL PONSETI® Move Bar is compatible with sizes 00 through 5.
Education on proper brace application and troubleshooting for skin issues is critical to ensure your child’s clubfoot correction is
eective. DO NOT USE this device without rst being trained by your physician or clinical team. Contact Customer Support for
assistance in locating training resources.
All products may not be available in your region, please check with your local distributor for more information.

5Document MD-124.2
3 Clubfoot Treatment Overview
Diagnosis
of Clubfoot
(at or before birth)
Treatment Phase
(6 to 8 weeks)
The doctor manipulates
and casts the child’s
foot (feet) using the
Ponseti Method.
1.
2.
3.
4. 5.
6.
7.
8.
Year 4
in AFO
Year 3
in AFO
Year 2
in AFO
Year 1
in AFO
End of your
Clubfoot journey
This info graphic provides that such medical information is merely information -
not advice. If users needmedical advice, they should consult a doctororother
appropriate medical professional. No warranties are given in relationship to the
medical information supplied andno liability will be accruedto MD Orthopaedics
in the event the usersuffers loss as a result of reliance upon the information.
Stage
1 - 2 - 3 - 4 - 5
Casting
Tenotomy Procedure
At the final casting,
the doctor releases the
Achilles tendon in
virtually all cases. Maintenance
The child is fitted with
the ankle foot orthosis
(AFO) and bar that are to
be worn 23 hours a day
for 90 days (3 months).
Sleep Maintenance
The AFO and bar are worn
when the child sleeps for
up to 4 - 5 years, as prescribed,
to ensure the correction holds.
Clubfoot JourneyTM
This infographic provides information — not advice. If you need medical advice, please consult a doctor or other appropriate medical
professional.
No warranties are given in relationship to the medical information supplied and no liability will be accrued to MD Orthopaedics in the event the
user suers loss because of reliance upon the information provided in this infographic.
Technical Characteristics
The MITCHELL PONSETI® AFO was designed with a soft, contoured elastomeric liner to cushion and hold the child’s foot in place. Straps
and abody made from a ductile synthetic suede that conforms to the shape of the foot for added comfort and stability. The AFO has
openings onthe side to add ventilation and keep the foot cool, and viewing holes to help gauge proper placement of the heel intheAFO.
Socks are required to eliminate skin contact with product.
The Quick Clips on the PONSETI® Abduction Bar and the MITCHELL PONSETI® Move Bar have been factory set to 60 degrees, the most
common bilateral clubfoot setting. This conguration may not correspond to your physicians preferred clubfoot setting. Please discuss
with your physician, orthotist, clinical team or healthcare provider before using this device.

6Document MD-124.2
3.1 MITCHELL PONSETI® Ankle Foot Orthotic
a. Liner
b. Tongue
c. Straps
d. Buckles
e. Sole
MD Orthopaedics’AFO Sizing Chart Legacy European AFO Sizing Chart
Length and width
measurement
locations
A
B
MITCHELL
PONSETI®
AFO Size
(A) Foot
Length(cm)
(B) Foot
Width(cm)
MITCHELL PONSETI®
AFOSize
(A) Foot
Length
(mm)
P6-0 5.5 to 6.5 2.5 to 4.0 P6-0 (Preemie 1) 60 to 62
P5-0 5.8 to 6.9 3.0 to 4.5 P5-0 (Preemie 2) 63 to 66
0000 6.0 to 7.3 3.3 to 4.8 0000 67 to 70
000 6.3 to 7.8 3.0 to 5.5 000 71 to 75
00 6.8 to 8.3 3.0 to 5.5 00 76 to 80
0 7.5 to 9.0 3.0 to 6.0 0 81 to 87
1 8.0 to 9.5 3.5 to 6.0 1 88 to 92
2 9.0 to 10.5 3.8 to 6.5 2 93 to 102
3 10.0 to 11.5 4.5 to 7.0 3 103 to 112
4 11.0 to 12.5 4.7 to 7.0 4 113 to 122
5 12.0 to 13.5 4.8 to 7.0 5 123 to 132
6 13.0 to 14.5 5.0 to 7.5 6 133 to 142
7 14.0 to 15.5 5.5 to 8.0 7 143 to 152
8 15.0 to 16.5 6.7 to 8.2 8 153 to 162
9 16.0 to 17.5 7.0 to 8.5 9 163 to 172
10 17.0 to 18.5 7.4 to 8.9 10 173 to 182
11 18.0 to 19.5 7.7 to 9.2 11 183 to 192
12 19.0 to 20.5 8.0 to 9.5 12 193 to 202
When tting the AFO it is recommended to size within the sizing parameters of the sizing chart. Please email us for
sizing assistance at [email protected].

7Document MD-124.2
3.2 MITCHELL PONSETI® AFO
Carefully inspect the AFO before each use. Never use an AFO or bar that is damaged, broken or not functioning properly, as these may
injure your child and/or render treatment ineective. Always use socks with the AFO to prevent direct contact with the skin.
Ensure the area is well lit and free from distraction to ensure you apply the AFO properly. Improper application of the AFO or bar can
lead to skin irritation, sores, and blisters.
1. Open the AFO so all the suede straps are clear for inserting the foot. Buckles are designed to be placed to the inside of the foot. They
may be positioned to the outside based on physician preference or individual convenience of application.
2. Holding the lower leg, gently slide the foot into place until the heel is secure against the back and bottom of the AFO. Socks that cover
the foot and lower leg are required to prevent skin contact with the AFO.
The exact position of the heel in the AFO will vary depending on the type and severity of the clubfoot. Forcing the heel into position
can lead to sores, so check with your physician to verify the proper position.
3. Pull tongue horizontally against the ankle and hold in place with your thumb. Be sure the hole in the tongue is set in the center of the
ankle, above the middle strap.
4. Buckle the middle strap securely over the horizontal tongue. Securely buckle the ankle strap but be careful not to overtighten, as that
can lead to skin irritation and sores.

8Document MD-124.2
5. Look through the heel viewing holes at the back of the AFO to ensure the heel is ideally down and to the back of the AFO. The heel
may not initially be able to contact the bottom of the AFO after the tenotomy and last casting but will over time. If you do not see the
heel in the viewing holes, readjust the tongue and middle strap so that the heel is properly positioned.
In some cases, the heel will not touch the bottom of the AFO, and in others the heel will be barely visible through the heel viewing
holes. In these challenging cases, the heel will drop over time as long as ankle motion is adequate. Forcing the heel into the AFO
and overtightening the middle strap can lead to skin irritation, sores, and reduced bracing compliance.
Once upper straps are tight and heel is securely in place, buckle the toe strap and retighten the other straps if needed.
3.3 PONSETI® Abduction Bar
The PONSETI® Abduction Bar was designed to be easily adjustable to the shoulder width of the child. The Quick Clips make it easy for
the bar to be attached and removed from the AFOs as needed.
A Quick Clip
B. Adjustable bar
C. Ponseti® Bar Lock
D. Heel Cap
E. Hex Key
PONSETI® Abduction
Bar Size Minimum Width (cm) Maximum Width (cm)
Extra Short 17.3 25.0
Short 20.0 30.0
Long 23.5 37.8
The PONSETI® Abduction Bar, size Extra Short Bar can be cut down as small as 11 cm, upon request.

9Document MD-124.2
The bar should be set so that the width of the bar is equal to the shoulder width of the child. Adjust the length of the bar, measuring
from the center screw of the left heel cap to the center screw of the right heel cap, so that it is equal to the shoulder width measurement.
It is important to measure the shoulder width regularly and adjustments should be approved by orthotist. When sizing the
Mitchell Ponseti® Abduction Bar, we recommend measuring from the right shoulder girdle to the left as you face the child
(asrecommended by the Ignacio Ponseti Foundation). See your Ponseti trained provider or your orthotist to make sure your width
is correct. Please email us for sizing assistance at [e-mail].
1. Use the enclosed hex key to loosen set screws in bar lock. Adjust the width of the bar to the child’s shoulder width, using the center
screw in the heel caps as a guide. Re-tighten the set screws in the bar lock.
2. Using a screwdriver, loosen center screw of heel cap; remove outer screw. Rotate clip to desired degree indicator to set abduction
(external rotation) as determined by your physician. Re-insert outer screw into appropriate hole. Tighten both screws.

10 Document MD-124.2
3. Insert clip into sole of AFOs until you hear a “click”. Verify that the bar lock and Quick Clips are engaged when assembled by pulling
on the AFO to make sure it does not disconnect from the bar. To disconnect the AFO from the Bar push rmly on“PUSH”while pulling
back on the bar until it slides free. If damage is found discontinue use andcontact Customer Service.

11Document MD-124.2
3.4 Mitchell Ponseti® Move Bar
A Quick Clip
B. Spring Capsule
C. Mitchell Ponseti® Bar Lock
D. Adjustable Bar
E. Arm
F. Hex Key
MITCHELL PONSETI®
Move Bar Minimum Width (cm) Maximum Width (cm)
Short 19.2 22.5
Medium 22.4 28
Long 27 37
The MITCHELL PONSETI® Move Bar has a dynamic range of 90 degrees. The mild spring tension will be easily overcome by your child’s
natural positioning. When in 0 degree/neutral position, the feet will be in a 10 or 15 degree dorsiexion based on healthcare provider’s
preference.
The bar should be set so that the width of the bar is equal to the measurements of the child’s shoulders.

12 Document MD-124.2
It is important to measure the shoulder width regularly and adjustments should be approved by orthotist. When sizing the
MITCHELL PONSETI® Move Bar, we recommend measuring from the right shoulder girdle to the left as you face the child
(asrecommended by the Ignacio Ponseti Foundation). See your Ponseti trained provider or your orthotist to make sure your width
is correct. Please email us for sizing assistance at [e-mail].
1. Use the enclosed hex key to loosen set screw in bar lock. Adjust the width of the bar to the child’s shoulder width, using the marking
on the bar. Re-tighten the set screw in the bar lock.

13Document MD-124.2
2. Using a screwdriver, loosen screw until able to turn the quick clip. Rotate clip to desired degree indicator to set abduction (external
rotation) as determined by your physician. Tighten screw. Repeat process with other quick clip.
3. Insert clip into sole of AFOs until you hear an audible“click”.Verify that Quick Clips are engaged when assembled by pulling on he AFO
to make sure it does not disconnect from the bar. To disconnect the AFO from the Bar push rmly on“PUSH”while pulling backon the
bar until it slides free. If damage is found, discontinue use and contact Customer Service.
When inserting clip into the AFO ensure grooves are engaged.
4 SAFETY INSTRUCTIONS
Use the MITCHELL PONSETI® Ankle Foot Orthosis (AFO), PONSETI® Abduction Bar and the MITCHELL PONSETI® Move Bar only
in accordance with these instructions and as directed by your physician, healthcare provider or other member of the clinical team.
Precautions/Cautions and Warnings:
• Read and understand this manual and its safety instructions before using this product. Failure to do so can result in injury.
• Use the MITCHELL PONSETI® Brace only in accordance with these instructions and as directed by your physician or other member
of the clinical team.
• Consult your physician, clinical team, or healthcare provider immediately if the child is experiencing pain, blisters, sores, visibly
slipping or if they are not in good condition or do not correctly t the child.
• Do not bend the bar or allow children to walk with the bar attached. Bending of the bar may compromise the therapeutic value,
lead to breakage and could negatively aect the correction.Walking with the bar attached puts the child at a high fall risk and may
cause breakage to the brace which could negatively aect correction.
• Do not over-tighten the adjusting screws.

14 Document MD-124.2
• Do not use the MITCHELL PONSETI® Brace if it is not in good condition or does not correctly t the child.
• Protect your child, yourself, and your furniture from being hit by the bar when the child is wearing it. It is recommended to pad the
bar with a PONSETI® Bar Cover.
• The MITCHELL PONSETI® Brace shall not be used without prescription by a physician or healthcare provider trained in the
PonsetiMethod and is to be used only as prescribed.
• The MITCHELL PONSETI® Brace shall not be used to treat any other orthopedic condition other than clubfoot unless otherwise
prescribed by the physician or healthcare provider.
• Altering the product and/or making after-market modications will void the warranty and may result in injury.
• Ensure the dressing area is well lit and free from distraction to ensure you apply the AFO properly.
• Improper application of the AFO or bar can lead to skin irritation, sores, and blisters.
• The MITCHELL PONSETI® Brace contains small pieces that may present a choking hazard. Ensure proper assembly to prevent
loose components around small children.
4.1 Safe Disposal
• The MITCHELL PONSETI® Brace and accessories can be disposed of in accordance with applicable local, state and federal
regulations. None of the components of the device are recyclable.
4.2 Potential Health Consequences
It is necessary that the brace be worn 23 hours a day for three months and then 12-14 hours a day (naps and nighttime) for 4-5 years
or as directed by your physician or healthcare provider. Incorrect use of the AFO may result in relapse of the clubfoot defect or injury
to thechild’s foot. If a user and/or patient experiences any serious incident that has occurred in relation to the device, it should be
reported tothe MD Orthopaedics, Inc. and the competent authority of the EU and EEA Member State in which the user and/or patient is
established.
Please contact MD Orthopaedics if you experience problems not outlined in this policy.
MD Orthopaedics, Inc.
604 North Parkway Street
Wayland, IA 52654 USA
www.mdorthopaedics.com
[phone] or e-mail [e-mail]
5 STORAGE AND TRANSPORT
5.1 How to Transport and Store the Product
The MITCHELL PONSETI® Ankle Foot Orthosis, PONSETI® Abduction Bar and the MITCHELL PONSETI® Move Bar ship at room
temperature and require no special handling during transport or storage.
6 MAINTENANCE
6.1 Reusing the Device
All parts were designed to be used by a single patient under normal use conditions and as prescribed by a physician.
Normal use includes the daily application of the AFO and MITCHELL PONSETI® Brace and use up to 23 hours per day, or as prescribed.
6.1.1 Cleaning the device
To clean the device:
1. Hand or machine-wash the AFO using cool water, a gentle cycle and mild detergent.
2. Let the AFO air dry completely before use.
3. It is not necessary to wash before using.
4. PONSETI® Abduction Bar and MITCHELL PONSETI® Move Bar can be properly cleaned by using a mild detergent and damp cloth.
Do not use hot water when washing the MITCHELL PONSETI® Ankle Foot Orthosis. This may cause the synthetic suede straps
towarp, shrink, separate or delaminate. Do not put the AFO into a mechanical dryer. Air dry only.
PONSETI® Abduction Bar and MITCHELL PONSETI® Move Bar should not be submerged.
6.2 How to Inspect the Product
The MITCHELL PONSETI® Ankle Foot Orthosis (AFO) and PONSETI® Abduction Bar should be inspected every time for proper t,
manufacturing defect, and damage prior to the device being placed onto the child’s feet.
Carefully inspect the MITCHELL PONSETI® Ankle Foot Orthosis (AFO), PONSETI® Abduction Bar and the MITCHELL PONSETI®
Move Bar before each use. Never use an AFO or bar that is damaged, broken or not functioning properly, as this may injure your
child and/or render treatment ineective. Contact Customer Service for Support, if needed.

15Document MD-124.2
7 TROUBLESHOOTING
7.1 How to Identify and Solve Problems
Hazard Cause Solution
Child develops blisters or other damage
to the skin Improper t and/or use Contact your physician or healthcare provider
Broken AFO Manufacturing defect or damaged via
normal use Contact your point of purchase
Broken AFO Damaged via normal use Contact your point of purchase
Broken Bar, Quick Clip, Heel Cap or
BarLock Damaged via normal use Contact your point of purchase
Incorrect Size (within 7 days of receipt) Sizing Error Contact your point of purchase
7.2 Frequently Asked Questions
Question Answer
Do the buckles go to the
inside of the foot or to the
outside of the foot?
The AFO was designed with the buckles set to the inside of the foot. This design feature is to aid
parents in the donning and dong of the AFOs. Ponseti experts do allow buckles to the outside of
the foot based on professional preference or customer convenience. Itwill not alter the performance
or risk of injury by orienting the buckles outward.
I just received my order, and
the AFOs seem too big/too
small. Is there a dierent size
that would work better?
Contact your point of purchase
The child’s heel is not down in
the AFO. Is something wrong?
If the heel is not visible in the viewing holes, check with your physician to ensure the clubfoot is fully
corrected. If the physician indicates that the correction is good, it may not be necessary to force the
heel down into the AFO, as this can lead to skin irritation, bracing discomfort, and reduced bracing
compliance.
How long will each pair of
AFOs last?
On average, an AFO will last 3-9 months. Some children grow rapidly and will need new AFO’s within
three months. As the child’s growth rate slows, more time can be expected from each AFO.
How long will the bar last?
The bars are adjustable and should last approximately more than one pair of AFOs. The bar width
should be periodically checked and adjusted to match the child’s shoulder width or as recommended
by your physician or orthotist.
Can I adjust the springs? The springs are set, and should not be adjusted.
Can child walk in the
PONSETI® Abduction Bar?
It is not recommended that the child walk in the Ponseti® Abduction Bar. Walking with the bar
attached puts the child at a high fall risk and may cause breakage to the brace which could negatively
aect correction.
Can child walk in the
MITCHELL PONSETI®
MoveBar?
It is not recommended that the child walk in the Mitchell Ponseti® Move Bar. Walking with the bar
attached puts the child at a high fall risk and may cause breakage to the brace which could negatively
aect correction.

16 Document MD-124.2
8 GLOSSARY
Term Meaning
Ankle Foot Orthosis (AFO) An AFO is a brace, usually made of plastic, that is worn on the lower leg and foot to support the ankle,
hold the foot and ankle in the correct position
Casting A procedure to keep the clubfoot in place after manipulation. Padding is wrapped around the foot, then
plaster or berglass is applied, and the cast is molded into place.
Clubfoot
(talipesequinovarus)
Clubfoot (Talipes equinovarus) is a common birth defect in which the foot is twisted out of shape or
position.
In clubfoot, the foot appears twisted and can even look as if it’s upside down. Despite its appearance,
clubfoot itself doesn’t cause any discomfort or pain.
Treatment is usually successful and includes stretching and casting (Ponseti Method) or stretching and
taping (French method). Sometimes, surgery is needed.
Dorsiexion Dorsiexion is the exion of the foot in an upward direction, from the ankle.
Equinus
Equinus is a condition in which the upward bending motion of the ankle joint is limited. Someone with
equinus lacks the exibility to bring the top of the foot toward the front of the leg. Equinus can occur in
one or both feet.
Foot Abduction Brace Abduction is a motion that pulls a structure or part away from the midline of the body. An abduction
brace keeps the foot in proper alignment with the midline.
Orthotist
An orthotist is a healthcare professional who makes and ts braces and splints (orthoses) for people
who need added support for body parts that have been weakened by injury, disease, or disorders of the
nerves, muscles, or bones
Ponseti Method
The Ponseti Method is a non-surgical clubfoot treatment process developed by Dr. Ignacio Ponseti.
Themethod utilizes gentle manipulation and casting to gradually move the foot into the correct
position.
Pressure Saddles A pressure saddle is a piece of soft, exible rubber that attaches to the middle strap of the AFO to
provide additional relief from the pressure of the strap.
Tenotomy
An Achilles tendon release, also known as tenotomy, is a surgical procedure that involves cutting
through the Achilles tendon to allow for nal dorsiexion of the foot. The procedure is used to correct
the equinus deformity seen in clubfoot.

17Document MD-124.2
9 SYMBOL LEGEND
Symbol Meaning Symbol Meaning
Ankle-Foot Orthotic (AFO) Caution
Authorized Representative in the European
Community Date of manufacture
Manufacturer Importer of record
Single Patient, Multiple Use Non-sterile
Indicates Item is a Medical Device Catalog number
CE Mark (in compliance with Regulation (EU)
2017/745 of the European Parliament and of the
council of 5 April 2017 on Medical Devices)
Batch code
Information considered important, but not
hazard-related Electronic Instructions for Use

Brugsanvisning
MITCHELL PONSETI® ankel-fodortose (AFO)
PONSETI®abduktionsskinne
MITCHELL PONSETI® ytteskinne
MD Orthopaedics, Inc.
604 North Parkway Street
Wayland, IA 52654 USA
www.mdorthopaedics.com
Dokument MD-124.2
Version 1
April 2023
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