CAMBER ORTHROS MIS User manual

SURGICAL TECHNIQUE GUIDE
PEDICLE SCREW FIXATION
ORTHROS MISTM
LIFE UPRIGHTTM
Camber
Spine
501 Allendale Road
King of Prussia, PA 19406
Phone: [phone]
cambermedtech.com

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TABLE OF CONTENTS
Important Information
Approach
Pedicle Preparation and Dilation
Screw Insertion
Rod Insertion
Secure the Rod
Screw Extension Removal
Optional Techniques
Removal Techniques
Set Contents
Additionally Available
Notes
4
5
8
11
13
17
19
21
23
24
27
29

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DESCRIPTION
The ORTHROS™ MIS Posterior Stabilization System consists of a variety of shapes and sizes of rods,
monoaxial screws, polyaxial screws, locking caps, locking set screws, and associated manual
surgical instruments. Implant components can be rigidly locked into a variety of congurations
for the individual patient and surgical condition. Polyaxial screws are intended for posterior and
anterior use. Rods and monoaxial screws may be used anteriorly or posteriorly. Locking caps and
locking set screws are used to connect screws to the rod. The rods are composed of titanium
alloy, as specied in ASTM F136. All other implants are composed of titanium alloy, as specied
in ASTM F136.
MATERIALS
All implants are manufactured out of Titanium Alloy, specically TAV- per ASTM F136.
IMPORTANT INFORMATION

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APPROACH
The patient is administered anesthesia and placed in the prone position. The operative area is
carefully cleaned and disinfected.
Using C-Arm uoroscopy, obtain an image to ensure patient spinous processes are aligned and
that the vertebral body endplates are parallel to one another.
INCISIONS
The incision points will depend on the approach and technique of the user. There are (4) general
incision types especially when dealing with a 1-Level fusion.
Using a scalpel, make an incision approximately 13mm in length to accommodate the
ORTHROS™ MIS pedicle screw outer diameter. Select the Bone Aspiration Needle (CM-123-01) or
the Cannulated Awl (Cannulated Awl Handle, CM-124-01 assembled to Cannulated Awl Trocar,
CM-124-02) to start the pedicle screw hole. Advance the instrument with the aid of uoroscopy
to the desired depth.
5
Incision for Bilateral Mini
Open using TLIF
Incision for Bilateral Mini
Open using PLIF
Incision for Left Mini
Open, Right MIS using TLIF
Incision for Left Mini Open
with TLIF, Right MIS

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Remove the inner shaft of the Bone Aspiration Needle and discard, or unthread and remove the
Cannulated Awl Trocar from the Cannulated Awl Handle.
Insert selected K-wire (CM-130-XX) to the desired depth while verifying using uoroscopy. The
insertion tip of the K-wire (CM-130-XX) is marked with a solid black band. Once the K-wire (CM-
130-XX) is placed, carefully remove the outer shaft of the Bone Aspiration Needle or Cannulated
Awl Handle. Use the succession of etched lines on the K-wire (CM-130-XX) as a visual indication
of unwanted translation of the K-wire (CM-130-XX).
Select style and material K-wire (CM-130-01):
Nitinol: Blunt, CM-130-01; Trocar, CM-130-02
Stainless Steel: Blunt, CM-130-03; Trocar, CM-130-04; Threaded, CM-130-05

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Repeat above incision technique for each pedicle. It is suggested to make all incisions prior to
continuing on to pedicle preparation.
Insertion Tip
Succession of Etched
Lines

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PEDICLE PREPARATION & DILATION
Insert the Cannulated Pedicle Probe (CM-129-01) over the K-wire (CM-130-XX). Twist the probe
into the pedicle to open the pathway into the vertebral body. Use the succession of etched
lines on the K-wire (CM-130-XX). The depth markings are etched in 15mm increments. Note the
length of K-wire (CM-130-XX) protrusion through the handle of the Pedicle Probe (CM-129-01) and
ensure that the K-wire (CM-130-XX) does not advance anteriorly during pedicle preparation. The
K-wire (CM-130-XX) Gripper (CM-102-02) can be used to secure the K-wire (CM-130-XX) position.
DILATION OPTIONS:
1. If using the 1-Step Dilator assembly, slide 1-Step Inner Dilator (CM-119-05) through 1-Step Outer
Dilator (CM-119-06).

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Slide the 1-Step Dilator assembly over the K-wire (CM-130-XX) & gradually press into the incision.
Once the 1-Step Dilator is touching the cortical wall of the pedicle, press the 1-Step Outer Dilator
down further into the incision preparing for the Taps. Remove the 1-Step Inner Dilator prior to
inserting the Taps.
Press in
assembly
Separate
Outer Dilator
Remove Inner
Dilator

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2. If using the 3-Step Dilator process, insert Aluminum
Dilator 1 (CM-119-07), followed by Aluminum Dilator 2
(CM-119-08) & Dilator 3 (CM-119-03) over the K-wire (CM-130-
XX). Dilators 1 and 2 are also available in PEEK upon special
request.
TAPPING FOR THE PEDICLE SCREWS
ORTHROS™ MIS Taps (ORM-134-XXXX) will center through the 1 Step Outer Dilator or Dilator 2.
Alternatively, attach the Tap to the Tap Sleeve (CM-134-10) for general dilation. If neuromonitoring,
use the PEEK Tap Sleeve (CM-134-11).
Select the appropriate diameter
Tap. The diameter of the Tap is
printed on the shaft. Attach
the Tap to the Tap Sleeve and
insert over the K-wire (CM-130-
XX). Use the tip of the Tap
Sleeve to dilate the incision.
Attach the Tap to either the
ratcheting Straight Handle (CP-
100-33) or ratcheting T-Handle
(CP-100-34) & tap the pedicle
to the desired depth, using
uoroscopy as needed.
PITCH INFO FOR TAPS AND SCREWS
TAP O.D. (MM) PITCH (MM)
4 0.75
4.5 0.9
5.5 0.9
6.5 1.25
7.5 1.25
SCREW O.D (MM) PITCH (MM)
4.5 0.75
5.5 0.9
6.5 0.9
7.5 1.25
8.5 1.25