NuVasive ERC 4P User manual

Patient Manual ERC 4P
Model: ERC 4P
LC0265-D 04/2022 Page 1of 54
External Remote Controller ERC 4P
Patient Manual

Patient Manual ERC 4P
Model: ERC 4P
LC0265-D 04/2022 Page 2of 54
CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN.
To Physicians: Reference the PRECICE ERC Operator’s Manual and PRECICE Instructions
for Use for clinical set-up and information for healthcare practitioners. Provide a copy of this
PRECICE ERC Patient Manual to each patient and review it with them before treatment. Make
sure to
record the patient’s prescription on the next page.
To Patients: Read this entire booklet before you use the PRECICE ERC. Refer to this booklet at
any time during your treatment. You can also talk to your doctor about any questions you have.
GENERAL CONTACT INFO:
101 ENTERPRISE, SUITE 100 | ALISO VIEJO, CA 92656 PHONE: [phone] | FAX: [phone]

Patient Manual ERC 4P
Model: ERC 4P
LC0265-D 04/2022 Page 3of 54
TABLE OF CONTENTS
1. MY PRESCRIPTION............................................................................................................................................... 4
2. SYMBOLS DEFINITIONS ...................................................................................................................................... 5
3. DEFINITIONS AND GLOSSARY........................................................................................................................... 7
4. INDICATIONS FOR USE: Why is PRECICE Used?.............................................................................................. 8
5. CONTRAINDICATIONS: Who cannot use the PRECICE system?....................................................................... 9
6. WHAT YOU MUST DO TO AVOID HARM (WARNINGS) ................................................................................12
7. WHAT ARE THE RISKS........................................................................................................................................16
8. PRODUCT DESCRIPTION....................................................................................................................................17
9. ABOUT THE ERC ..................................................................................................................................................21
10. IMPLANT DETECTION FEATURES ...................................................................................................................22
11. SET UP INSTRUCTIONS. (BEFORE YOU DO TREATMENT)..........................................................................22
12. HOW TO USE THE ERC .......................................................................................................................................24
13. CHARGING THE ERC..........................................................................................................................................39
14. INSPECTING, CLEANING, STORING AND OTHERINFORMATION ............................................................42
15. MORE ABOUT YOUR CONDITION ....................................................................................................................44
16. TROUBLESHOOTING. (ERRORS).......................................................................................................................45
17. SPECIFICATIONS .................................................................................................................................................50

Patient Manual ERC 4P
Model: ERC 4P
LC0265-D 04/2022 Page 4of 54
1. MY PRESCRIPTION
Date
Implant
Location
Distance Per Session
(example: 0.25mm)
Sessions Per Day
(example: 4 times/day)
Daily Total
(example: 1.00mm)
Where to place the ERC during each session:
(Circle the general location – there will be a specific mark on your leg or arm)
IMPLANT #1
 Right Leg
 Left Leg
 Right Arm
 Left Arm
 Tibia
 Femur
 Humerus
RIGHT SIDE
LEFT SIDE
Humerus
Femur
Tibia
Humerus
Femur
Tibia
IMPLANT #2
 Only One Implant
 Right Leg
 Left Leg
 Right Arm
 Left Arm
 Tibia
 Femur
 Humerus
Special Notes (example: always use crutches):
Need help? Call:
My Provider:
Phone:
My Doctor:
Phone:

Patient Manual ERC 4P
Model: ERC 4P
LC0265-D 04/2022 Page 5of 54
2. SYMBOLS DEFINITIONS
For Symbols Glossary, please refer to https://www.nuvasive.com/eifu/symbols-glossary
For Symbols specific to the ERC 4P reference the table below.
Symbol
Definition
IPX0
The device offers no special protection from fluid
ingress.
Go Back key(s): These are touch screen keys that
provide a method to go back to a previous screen or
software state when they are displayed and pressed by
the user.
Continue Key: This is a touch screen key that provides a
method to advance to the next screen or software state
when it is displayed and pressed by the user.
Reset Value Key: When displayed, this touch screen key
next to a value displayed allows the user to reset it when
it is pressed.
Clinical Key: This touchscreen key provides a method
for a clinician to access software modes limited to non-
patients. Accessing these modes requires a passcode.
Clinical Key (During Patient Mode): This touchscreen
key provides a method for a clinician to access software
modes limited to non-patients. Accessing these modes
requires a passcode.
Control Button, Blinking Green: A digital button on the
touch screen display is used by users to begin therapy.
Control Button, Solid Red: A digital button on the touch
screen display is used by users to pause or stop therapy
at any time.
Alignment Line: This line symbol labeled on the ERC
4P identifies the center of the ERC 4P magnet length. It
can be used as method to align the ERC magnet to the
implant magnet based on the lines or sutures located on
the patient’s limb.

Patient Manual ERC 4P
Model: ERC 4P
LC0265-D 04/2022 Page 6of 54
ERC 4P Position Orientation with ARROWS: This
symbol and labeling indicates the orientation of the ERC
4P relative to the patient. The patient should be able to
view this symbol with arrows pointed toward their feet.
LEFT indicates the left side of the unit is positioned to
the left side of the patient. RIGHT indicates the right
side of the unit is positioned to the right side of the
patient.
ERC 4P Position Orientation with ARROWS: This
symbol and labeling indicates the orientation of the ERC
4P relative to the patient.
Uncoupled Implant Detection: This symbol displayed
indicates that the ERC 4P does not detect the implant
magnet or its rotation.
Coupled Implant Detection: This symbol displayed
indicates the ERC 4P has detected the implant magnet
and it is properly rotating.
Anatomic Instruction Screen
The patient’s specific left or right side femur, tibia, or
humerus will be highlighted on the screen to identify the
exact limb with the PRECICE implant. There are six (6)
possible locations for the implant, only one will be
shown with a solid purple color.
System Error Screen
This screen will appear on the control panel when there
has been an error with the operation of the ERC 4P.
In this figure “CODE: 104” is given as an example. The
screen may have a different code and information
shown.

Patient Manual ERC 4P
Model: ERC 4P
LC0265-D 04/2022 Page 7of 54
3. DEFINITIONS AND GLOSSARY
This section gives definitions to words that are used in this guide.
Active Medical Device: The term "active" means any medical device that needs a power supply.
Power can be supplied by any means including electricity, battery, or gas. Examples of active
devices include ventilators, pacemakers, and patient monitoring devices.
Actuator: The part of the PRECICE device that can change in length when activated.
Contraindication: Any condition that renders using the PRECICE system undesirable
or inadvisable.
Coupling: Pairing of the ERC to the PRECICE device magnetically.
Distract: Distract means to extend or lengthen. The PRECICE system is used to distract
or retract bones.
Retract: Retract means to shorten. The PRECICE system is used to distract or retract bones.
Electronic Device: This refers to any device that has a power cord that is plugged in
for electrical power or is battery operated. Examples include computers and cell
phones.
ERC: ERC refers to External Remote Controller. The ERC is used to adjust the PRECICE
device that is in your leg or arm from outside of your body. The ERC system consists of the
ERC and Charging Cord.
Femur:The femur is the thigh bone in the leg. It is the largest bone of the body and is situated
between the hip and the knee.
Humerus: The humerus is the upper arm bone. This is the bone located between the shoulder
and elbow joint.
Implant: An implant is a device that is inserted into the body for a period of time.
Intramedullary: Intramedullary refers to being inside the bone.
MRI: MRI refers to Magnetic Resonance Imaging, which is a medical technique to
visualize structures inside the body.
Osteopenia: Osteopenia is a condition where the density of your bone is lower than normal.
Pacemaker: An artificial device for stimulating the heart muscle and regulating its contractions.
PRECICE Device: The PRECICE device is the adjustable implant that is implanted into
your leg bone (tibia or femur) or arm bone (humerus). It is lengthened by the ERC from
outside your body.
Regenerate: Regenerate refers to new growth. In this manual, it refers to new bone tissue
growth.
Tibia: The tibia (or shinbone) is the large leg bone between the knee and ankle.
Troubleshooting: The process of solving problems or determining why something does not
operate correctly.

Patient Manual ERC 4P
Model: ERC 4P
LC0265-D 04/2022 Page 8of 54
4. INDICATIONS FOR USE: Why is PRECICE Used?
The NuVasive Specialized Orthopedics, Inc. (NSO) External Remote Controller, model
ERC 4P, is a portable hand-held system used to non- invasively distract or retract the Precice
Systems.
The Indications for Use of the ERC 4P when used with the Precice System (inclusive of Precice
IMLL, Precice Unyte, Precice Stryde, and Precice Bone Transport) is indicated for limb-
lengthening, open and closed fracture fixation, pseudarthrosis, mal-unions, non-unions or bone
transport of long bones.
The Indications for Use of the ERC 4P when used with the Precice Plating System is indicated for
limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions and non-unions
of long bones in pediatrics and small stature adult patients.
The Indications for Use of the ERC 4P when used with the Precice Ankle Salvage System is
intended for tibio-talo-calcaneal fusions. When used for TTC fusion, the Precice Ankle Salvage
System may be used for open and closed fracture fixation, pseudarthrosis, mal-unions, non-unions,
or bone transport of long bones adjacent to the fusion site. The device may be used for subsequent
limb lengthening once tibio-talo-calcaneal fusion has been achieved.
After your doctor implants the PRECICE implant into your limb, you will use the ERC to make
the device longer or shorter. The lengthening/shortening phase usually starts 5 days after your
surgery. You will make the PRECICE implant a small amount longer or shorter each day (usually
about 0.75 to 1 millimeter each day). This phase of your treatment could last up to 80 days. Your
doctor will tell you how much and how often to adjust the PRECICE implant. Usually once a week
you will visit your doctor to check on your progress. Your doctor may x- ray your leg or arm
during these visits. For femur or tibia implants, your doctor will also tell you to use crutches and
avoid putting weight on your leg with the PRECICE implant. For humerus implants, your doctor
will tell you to avoid using and putting weight on your arm with the PRECICE implant. A good
result requires your active cooperation and dedication to certain tasks. If you do not follow your
doctor’s instructions, you could seriously harm yourself.
After your leg/arm has reached its goal length, you will stop using the ERC. This will let your
bone heal.
During the consolidation phase, the bone heals. Your bone will change, or regenerate, from a soft
material into hard bone over time. This healing process usually takes about 2 months for every
inch that your bone has been lengthened or shortened. During this healing phase, it is very
important that you follow all of your doctor’s instructions. You will continue to see your doctor
for visits, usually once a month.

Patient Manual ERC 4P
Model: ERC 4P
LC0265-D 04/2022 Page 9of 54
5. CONTRAINDICATIONS: Who cannot use the PRECICE system?
Important Safety Information – Read Before Use!
Please read and consider the information in this guide before deciding
on your treatment.
This section describes the Contraindications for the PRECICE Systems. If you have any of these
contraindications, you cannot use a PRECICE device.
CONTRAINDICATIONS:
Your doctor will check the following to see if you would be a good fit for PRECICE (inclusive of Precice
IMLL Precice Unyte, Precice Stryde and Precice Bone Transport):
xPatients with an irregular bone diameter that would prevent insertion of the Precice nail
xPatients in which the Precice nail would cross joint spaces or open epiphyseal growth plates
xPatients in which there is an obliterated medullary canal or other conditions that tend to retard healing
such as blood supply limitations, peripheral vascular disease or evidence of inadequate vascularity
xPatients unwilling or incapable of following postoperative care instructions
xInfection or Pathological conditions of bone such as osteopenia which would impair the ability to
securely fix the device.
xPatients with Gusilo open fracture Classification Grade IIIB or IIIC fractures
xPatients with pre-existing nerve palsies
xMetal allergies and sensitivities
Precice Bone Transport has the following additional contraindications:
xPatients with maximum bone defect of more than 100 mm.
xPatients with excessive skin damage and not enough soft tissue covering where the fracture
sites.

Patient Manual ERC 4P
Model: ERC 4P
LC0265-D 04/2022 Page 10 of 54
Please refer to the tables below for contraindications with regard to weight and maximum distance of the
treated limb to the surface of the intramedullary canal.
For Precice & Precice Unyte Nail
Limb PRECICE
Model Nail Diameter
Maximum Distance of
Treated Limb to Surface
of IM Canal
Maximum
Patient Weight
Tibia
C
8.5 mm, 9.0 mm, 9.5 mm,
10.0 mm, 10.5 mm 13 mm 57 Kg
10.7 mm, 11.5 mm, 12.5 mm
16 mm
114 kg
J
8.5 mm
13 mm
57 Kg
10.7 mm, 12.5 mm
16 mm
114 kg
Q
8.5 mm
13 mm
57 Kg
10.7 mm
16 mm
57 Kg
Femur
A-G (except
C), V, X
8.5 mm, 9.0 mm, 9.5 mm,
10.0 mm, 10.5 mm
45 mm 57 kg
10.7 mm, 11.5 mm
75 mm
114 kg
12.5 mm
90 mm
114 kg
H, K, U
8.5 mm
45 mm
57 kg
10.7 mm
75 mm
114 kg
12.5 mm
90 mm
114 kg
N, M, P
8.5 mm
45 mm
57 kg
10.7 mm
75 mm
57 kg
Humerus L, M 8.5mm
165 - 210 mm
pre-distracted
length
25 mm Non-weight
bearing
225 - 300 mm
pre-distracted length
45 mm
Non-weight
bearing
For Precice Stryde Nail
Limb
PRECICE
STRYDE
Model(s)
Nail
Diameter
Maximum Distance of
Treated Limb Surface to
IM Canal
Maximum
Patient
Weight
Tibia C, SJ
10.0
13mm
150 lbs / 69 kg
11.5
16mm
200 lbs / 91 kg
13.0
16mm
250 lbs / 114 kg
Femur A, B, C,
E, V, X
10.0
70mm
150 lbs / 69 kg
11.5
85mm
200 lbs / 91 kg
13.0
100mm
250 lbs / 114 kg
For Precice Bone Transport Nail
Limb
PRECICE Bone
Transport
Model
Nail Diameter
(mm)
Maximum Distance of
Treated Limb Surface
to IM Canal
Max. Patient Weight
Bearing
Use with partially
threaded screws
Max. Patient Weight
Bearing
Use with fully threaded
screws
Tibia
C, SJ
10.0
19mm
25lbs/11kg
25lbs/11kg
11.5
19mm
190lbs/86kg
125lbs/57kg
13.0
19mm
250lbs/114kg
125lbs/57kg
Femur
A, B, BT, D, DT,
E, V, X, SE, SB,
SD, SA
10.0
64mm
25lbs/11kgs
25lbs/11kg
11.5
69mm
190lbs/86kg
125lbs/57kg
13.0 85mm 250lbs/114kg 125lbs/57kg

Patient Manual ERC 4P
Model: ERC 4P
LC0265-D 04/2022 Page 11 of 54
Your doctor will check the following to see if you would be a good fit for Precice Plating System:
xInfection or bone disease that would prevent successful use and operation of the device.
xPatients with Gustilo-Anderson open fracture Classification Grade IIIB or IIIC fractures
xMetal allergies and sensitivities.
xFor the femur, patients whose distance from the skin surface to the Precice Plate is greater than 38mm.
For the tibia, patients whose distance from the skin surface to the Precice Plate is greater than 20mm.
xPatients with a non-regular bone shape/size that would prevent placement of the Precice Plate.
xPatients whose condition tend to prevent healing such as blood supply limitations, peripheral vascular
disease or evidence of inadequate vascularity.
xPatients unwilling or incapable of following care instructions after a surgical operation.
Your doctor will check the following to see if you would be a good fit for Precice Ankle Salvage System:
xInfection or bone disease that would prevent successful use and operation of the device.
xPatients with poor quantity or quality of bone that prevents stabilization or fusion of the joints.
xPatients with an insufficient plantar pad.
xPatients having an intact asymptomatic subtalar joint.
xPatients with Gustilo open fracture Classification Grade IIIB or IIIC fractures.
xMetal allergies and sensitivities.
xPatients with a non-regular bone diameter that would prevent insertion of the Precice Ankle Salvage
nail.
xPatients in which there is an overly damaged medullary canal or other conditions that tend to prevent
healing such as blood supply limitations, severe peripheral vascular disease or evidence of inadequate
vascularity.
xPatients with severe deformity in the length of the bone
xPatients with poor tibial alignment (>10 degrees in either sagittal or coronal plane)
xPatients unwilling or incapable of following care instructions after a surgical operation.
xPatients whose maximum distance of treated limb surface to inner marrow space exceeds 25mm.

Patient Manual ERC 4P
Model: ERC 4P
LC0265-D 04/2022 Page 12 of 54
6. WHAT YOU MUST DO TO AVOID HARM (WARNINGS)
This section describes the Warnings associated with the ERC 4P. This will help you to avoid
serious harm when using the ERC 4P. Please read all of these warnings before you use the
ERC 4P.
1. WARNING *
Weekly X-ray imaging to assess actual distraction length is recommended for
patients undergoing lengthening.
2. WARNING *
During and after compression, X-ray imaging is recommended to assess
compression and bone healing.
3. WARNING *
Proper training of the External Remote Controller is required prior to
operating this device. Only use the External Remote Controller in a manner
consistent with this Operator’s Manual. Any alternative use may result in
injury or damage to property.
4. WARNING *
This equipment may cause radio interference or may disrupt the operation
of nearby equipment. It may be necessary to take mitigation measures, such
as re-orienting or relocating the External Remote Controller or shielding the
location.
5. *WARNING*
This device has not been tested for compatibility in Magnetic Resonance
Imaging (MRI) environments and should not enter an MRI unit.
6. WARNING
*
Persons with a pacemaker or a similar medical aid should not handle or be
exposed to the External Remote Controller. The strong magnetic fields may
affect the operation of such devices.
7. CAUTION
*
The Rare-Earth Magnetics Association is not aware of any positive or
negative health effects from handling rare-earth magnets. However, it is
recommended that pregnant women not handle very strong rare-earth
magnets (ERC).
8. WARNING
*
The External Remote Controller uses a strong permanent magnet. Misuse of
this system can cause serious personal injury. Always maintain a firm grip
on the External Remote Controller and be aware of other objects in your
work area. The External Remote Controller may be pulled away from your
hands, or items may be pulled toward it if brought too close to other
magnetic objects.
Make sure there is at least 2 Feet (60 centimeters) around the work area that
is free of metal objects such as instruments and tools before use. This
includes personal items such as jewelry, watches, keys, and cellular phones.
Do not use the ERC with metal/magnetic objects within the designated
vicinity.

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Model: ERC 4P
LC0265-D 04/2022 Page 13 of 54
9. WARNING
*
If this equipment is damaged, beware that magnet shards from broken
magnets are very sharp. Always handle broken magnets with thick
protective gloves. Contact NuVasive Specialized Orthopedics if the ERC is
damaged.
10. WARNING
*
Never place the External Remote Controller near electronic media or
appliances. The strong magnetic field may damage magnetic media such as
floppy disks, credit cards, magnetic I.D. cards, cassette tapes, video tapes or
other such devices. It can also damage televisions, VCRs, computer monitors
and other CRT displays.
11. WARNING
*
Never operate ERC in an oxygen enriched or flammable environment.
12. WARNING
*
There are no user serviceable components inside this device. Do not open the
unit. Severe personal injury or damage to the equipment may result.
Service should only be performed by qualified personnel.
13. WARNING
*
Only use the supplied charging cord for the ERC. Contact NuVasive
Specialized Orthopedics for a replacement charging cord.
14. WARNING
*
Do NOT use this equipment in the presence of flammable anesthetics.
15. *WARNING*
The ERC should only be placed immediately over the area of the patient’s
body at the magnetic portion of the implant. Do not place the ERC near any
other parts of the body, for example, portions of the body which may contain
ferromagnetic material containing implants. When the ERC is not being
actively used on the patient, it should always be kept within its protective
case.
16. *WARNING*
Do not leave the ERC unattended around children. The ERC is not intended
to be used by anyone under the age of 18. Use of this device by anyone under
the age of 18 may result in improper use which may result in the need for
another surgery.
17. *CAUTION*
Although there is no evidence of neurological/soft tissue damage, the
physician should consider it when prescribing for a longer session of
distraction or retraction length.
18. *WARNING*
Do not operate the ERC if it is dropped from a height of 3 feet or greater. If
there is physical damage to the unit (e.g. unexpected noise, cracks) do not
operate. If this does occur, please call the manufacturer NuVasive
Specialized Orthopedics, Inc. and a replacement unit will be provided.

Patient Manual ERC 4P
Model: ERC 4P
LC0265-D 04/2022 Page 14 of 54
19. *WARNING*
Do not lift the ERC unit using the adapter cord. Please return with ERC.
20. *WARNING*
Always follow the prescription and instructions from your doctor when using
the ERC. If you do not follow your prescription, your bone could heal
improperly or not at all.
If you use the ERC less often than your doctor prescribes, your bone might
harden too early. It will also stop getting longer or shorter before it has
reached its target length. If this happens, you may need another surgery to
make your bone the right length.
If you use the ERC more than your doctor prescribes, you could lengthen or
shorten the bone too quickly. This causes your bone to heal improperly or
not at all. If this happens, you may need another surgery to treat the bone
that will not heal.
21. *WARNING*
Always put the ERC on the skin right over the implant and in the
correct direction. Placing the ERC in the wrong location on your leg or
arm could result in the bone not lengthening or shortening correctly.
Your bone could harden too early if it is not lengthening or shortening
correctly. You may need another surgery to make your bone the right
length.
22. *WARNING*
Align the ERC toward the patient’s feet as in the picture below. The
Display screen should be facing you so it can be read. If the ERC is
pointing in the wrong direction, the PRECICE implant will not
lengthen or shorten properly and may result in the need for another
surgery. This figure shows the correct direction to point the ERC.
23. *WARNING*
To avoid infection, do not place the ERC on any open sore on your
skin. You may need medical intervention or surgery to treat an
infection. An open sore is any cut on your skin.
24. *WARNING*
Always discuss any pain or discomfort you are having with your
doctor. This treatment may cause some pain and discomfort. This
could be a normal part of your treatment or a symptom of other issues.
Your doctor may want to adjust your prescription during your
treatment if you are experiencing pain or discomfort.

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Model: ERC 4P
LC0265-D 04/2022 Page 15 of 54
25. *WARNING*
Before you use the ERC, make sure you receive training from your
doctor or nurse. Improper use of the ERC could cause your bone to
harden too soon or not at all. This could result in the need for another
surgery.
26. *WARNING*
Follow the instructions your doctor gives to you about how much
weight to put on your leg or arm during your treatment. If you put
more weight on your leg or arm than your doctor recommends, the
implant could be damaged or break. This could result in the need for
another surgery.
27. *PRECAUTION*
Do not store the ERC near any areas that may have extreme
temperatures. Some areas may include a heater or fireplace. Extreme
temperatures would be anything above 140ºF/60ºC or below 14ºF/-
10ºC. The ERC has not been tested in those temperatures and may not
work correctly. Refer to the Troubleshooting section if you
have any problems with the ERC.
28. *PRECAUTION*
Act on all error messages. Refer to the Troubleshooting section to
learn how to respond to an error message. Failure to take action after
an error message could result in the ERC not working properly.

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Model: ERC 4P
LC0265-D 04/2022 Page 16 of 54
7. WHAT ARE THE RISKS
There are risks of the surgery to implant the PRECICE implant into your limb. The anesthesia
and surgical risks are the same as for any patient who undergoes a surgical procedure. The
risks listed could result in the need for additional medical or surgical procedures tocorrect.
The risks associated with anesthesia and surgery include:
xYou could have a reaction to the medicines given to you during the surgery.
xYou could get an infection during or after the surgery.
xYou could have an embolism during or after the surgery.
xYou could experience some stiffness or soreness from the surgery.
xYou could experience some pain from the surgery.
xYou could experience some bleeding from the surgery.
xYou could have an allergic reaction to the medicines.
xYou could have an allergic reaction to the devices used to treat you during the surgery.
xYou could have a stroke from the surgery.
xYou could have a heart attack (Myocardial infarction) from the surgery.
xYou could get pneumonia from the surgery.
xYou could die from the surgery.
The additional potential risks of the limb lengthening/shortening procedure include:
xYou may feel pain from lengthening or shortening your bone.
xThere may be a delayed union or non-union of the bone (the bone does not heal).
xThe screws may pull out or break.
xThere may be an infection.
xThe implant may malfunction or break.
xThe bone can consolidate (harden) before the lengthening or shortening is complete.
xYou may have stiffness of the soft tissue in your limb that may cause pain.
xYou may experience muscle weakness from not using the implanted limb.
xYou may experience nerve injury.
The additional risks associated with the use of the ERC include:
xMisalignment or improper location of the ERC can result in the implant not
lengthening or shortening which could result in premature bone consolidation.
xPlacing the ERC in the wrong direction can result in the opposite treatment
(lengthening/shortening) of the implant rather than the prescribed treatment. Note that
the implant cannot be shortened less than its initial programmed length.
xOver distraction or retraction could occur due to improper programming of the ERC
by the physician. This could result in non-union of your bone.

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Model: ERC 4P
LC0265-D 04/2022 Page 17 of 54
8. PRODUCT DESCRIPTION
The PRECICE System (inclusive of Precice IMLL, Precice Unyte, Precice Stryde, Precice Bone
Transport, Precice Plate, and Precice Ankle Salvage) includes:
xAn implant that goes into your leg or arm bone and is capable of adjusting in length
o The actuator is the part of the device that can change in length when activated
xScrews that attach the device to your bone
xAn External Remote Controller (ERC)
The implant has a part called an “actuator” that can change length. The actuator has a small
magnet that allows the implant to get longer or shorter when the magnet is turned by the ERC.
The ERC is a hand-held device with a large magnet. The magnet in the actuator turns when the
ERC is placed on your leg or arm and turned on. When the implant gets longer, your leg or arm
bone will also get longer. When the implant gets shorter, your leg or arm bone will also get
shorter.
Figure 1: PRECICE device implanted in the Femur

Patient Manual ERC 4P
Model: ERC 4P
LC0265-D 04/2022 Page 18 of 54
PRECICE Tibia Device
a. What happens during and after the treatment?
There are 4 phases to your treatment.
1) Implantation: This phase is when you have your surgery. Your doctor implants the
PRECICE implant in your limb.
2) Lengthening/Shortening: You will make your leg or arm longer or shorter each day in
this phase. About 5 days after your surgery, you will visit your doctor to have your first
lengthening or shortening. Your doctor will watch you while you use the ERC to make
your leg/arm longer or shorter and answer any questions you might have. When you
are at home, you will use the ERC to make your leg/arm a little longer or shorter each
day (usually about 1 mm per day). Make sure you follow your doctor’s instructions.
You will visit your doctor about once a week to check on your progress. Your doctor
may x-ray your leg/arm when you visit.
3) Consolidation: After your leg/arm is the right length, you will
stop lengthening or shortening your leg/arm each day. Now
you will let your leg/arm bone heal and get stronger. This is
the consolidation phase. Your doctor will see you about once a
month during this phase to check on your progress. Your
doctor will tell you how much weight you can put on your leg
or arm. It is important to follow all of your doctor’s
instructions.
4) Removal: The PRECICE implant will need to be removed from your leg or arm within
a year of your surgery. Your doctor will schedule another surgery to remove the
PRECICE implant. You will then stay in the hospital after the surgery until you heal
enough to go home. Your doctor will tell you when you can continue your usual
lifestyle after you have fully healed from your surgery.
b. What happens after the surgery?
xImplantation: You will stay in the hospital after the surgery to implant the PRECICE
implant in your limb. You will get to go home once you heal. You will visit the office
regularly to check if your lengthening or shortening is on track.
xPost-Removal: You will stay in the hospital after surgery to remove the PRECICE
implant from your limb. You will get to go home once you heal.

Patient Manual ERC 4P
Model: ERC 4P
LC0265-D 04/2022 Page 19 of 54
Figure 2: ERC for the PRECICE System
c. Getting to know your ERC
Inside your ERC Case, you will find the ERC and Patient’s Manual. The critical parts of
the ERC are labeled below:
Charging Cord
Tibia Handle
Display Screen
(touch screen)
Carrying
Handle
Alignment Lines

Patient Manual ERC 4P
Model: ERC 4P
LC0265-D 04/2022 Page 20 of 54
Figure 3: ERC Case