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

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The user may choose to undersize the Tap for the pedicle screw
diameter selected. When using Ø5.5mm pedicle screws and the
user wants to undersize the Tap, a Ø5.0mm Tap is available in the
set.
SCREW INSERTION
Prior to implanting the pedicle screw, the user must identify the
correct length of the screw selected. The length of the screw can
be determined with (2) instrumented options:
SCREW LENGTH INDICATION OPTIONS
Insertion
Orientation
Arrow
Indicating
55mm
Pedicle
Screw
1. During 3 step dilation, (above), slide the Screw Length
Indicator (CM-137-03) over the K-wire (CM-130-XX). Ensure
Dilator 1 is contacting the posterior wall of the pedicle. The
K-wire (CM-130-XX) must have been inserted properly to
ensure an accurate screw length indication. The orientation
arrow on the Screw Length Indicator should be pointing at
the patient as shown. The central band on the K-wire (CM-
130-XX) will work with the Screw Length Indicator scale to
estimate screw length.
2. If using a Tap Sleeve, the scale on the Tap Shaft will
indicate the estimated screw length based on the proximal
surface of the Tap Sleeve (CM-134-XX) (Right photo)
Indicating
50mm
Pedicle Screw

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SCREW INSERTION
The selected pedicle screw should be removed from the module. Take the T25 MIS Polyaxial
Screwdriver, ¼” Quick Connect (CM-117-02) & attach it to either the Straight Handle or the
T-Handle. Pedicle Screws can be implanted through Dilator 3.
Once the T25 Hexalobe Screwdriver Tip (CM-117-02) is seated in the bone
screw, turn the outer dial clockwise, engaging the locking set screw thread.
Turn the dial until it is hand tight.
Note: The user may reverse the ratcheting rotation of the handles to increase
the tension between the pedicle screw and screwdriver. Before inserting
each screw, check that the screw is rigid to the screwdriver.
To remove the T25 MIS Polyaxial Screwdriver, ¼” quick
connect (CM-117-03) from the pedicle screw, turn
the outer dial counterclockwise until the screwdriver
loosens from the pedicle screw.
Repeat steps for all pedicle screws. Verify positions of
all Pedicle Screws using uoroscopy. If Pedicle Screws
need AP adjustment, use the T25 Screwdriver W/ Swivel
C ap (C P -117- 5 4).
Once the Pedicle Screws are implanted, remove each
K-wire (CM-130-XX) carefully with the K-wire Gripper
(CM-102-02).

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If Dilator 3 was used, it should also be removed once the pedicle
screws are implanted. Adjust the screw head position(s) with
the Screw Head Positioner (CM-131-01) if needed. Orient screw
heads as shown below to ensure easy rod implantation.
ROD INSERTION
DISSECTION
The Ø5.5mm rods are all bullet-nosed to dissect tissue as the
user implants the rod. Prior to inserting the rods, the Dissector
(CM-102-01) can be used to create a pathway through the
tissue below the fascia layer. The Dissector can be inserted
cranially or caudally of the construct but shall follow the
anticipated rod trajectory.

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ROD LENGTH ESTIMATION
The length of the rod can be estimated using the Rod
Length Indicator (CM-137-02). Insert both shafts of the Rod
Length Indicator into the most superior and inferior screws.
The scale marked on the indicator’s caliper will estimate
the rod length for the construct.
ROD INSERTION
Select the appropriate length rod from the implant module. Take the Rod Inserter (CM-103-02)
and turn the knob clockwise to prepare for rod insertion. Once the dial stops, the inserter is ready
for the rod.

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Find the Front Side indicator marking on the Rod Inserter. The
rod engages the Rod Inserter from this side only. The rod will
not lock to the Rod Inserter if loaded backwards. Once
the rod is fully seated within the Rod Inserter, thread the dial
counterclockwise nger tight. Once nger tight, the rod will be
rigid to the Rod Inserter.
Front Side
Laser etched
Marking
Slowly insert the rod into the most superior pedicle screw (as shown) or most inferior pedicle screw.
Ensure the bulleted tip of the rod is below the fascia tissue layer.

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To verify the Rod is within each screw head, use the Rod Position Indicator (CM-137-01). The Rod
Position Indicator has two bands around the shaft. If the band is above the screw head top
surface, the rod is within the screw head. If you cannot see the band, the rod is not within the
screw head. The two bands correspond to the standard and long screw head options. Once
the user has obtained the nal position of the rod, do not remove the Rod Inserter at this time.
If the rod curvature needs to be changed, use the Rod Bender (CP-132-38) to achieve desired
contour the rod.
Rod within Screw Head
Rod is not within Screw Head

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SECURE THE ROD
INSERT LOCKING SET SCREW
Prior to releasing the Rod Inserter, the rod must be secured within each screw head. Ensure that
the bulleted tip of the rod has clearly passed through the screw head prior to securing the rod
to ensure proper construct locking.
Use the T30 Self-Retaining Screwdriver, ¼” Quick Connect (CM-117-03) to grab the
MIS Locking Set Screw (CM-002-10). Slowly drop the T30 Screwdriver (CM-117-04) with
Locking Set Screw (CM-002-10) into the rst screw head. Once the Locking Set Screw stops,
start to thread the Locking Set Screw into the screw head. Repeat this step for each screw.
The Locking Set Screw thread provides up to 25mm of rod reduction. Provisionally tighten each
Locking Set Screw.
The user may now turn the knob
on the Rod Inserter (CM-103-02)
clockwise, releasing it from the rod.
Carefully remove the Rod Inserter
(CM-103-02) from the incision.

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FINAL TIGHTENING
To nal tighten or lock the pedicle screw construct, attach the T30 Screwdriver, ¼” QC (CM-117-
04) and assemble it to the 8.5 N-m Final Tightening Handle, Torque Limiting (CC-100-53). Select a
Counter Torque to use the T30 screwdriver through: External Counter Torque (CM-132-03) or Counter
Torque (CM-132-01). Slide the T30 screwdriver into the selected Counter Torque and engage the
drive mechanism in each Locking Set Screw (CM-002-10). Turn the handle under the Torque Limiting
Handle (CC-100-53) clicks, indicating that it has reached 8.5Nm of torsional force.
When the External Counter Torque (CM-132-03) is fully engaged over the rod and screw head, the
lower window is lled completely with the screw head color. The upper window will be lled when
using the long screw head. When the External Counter Torque is not fully engaged, the window is
not lled, or is only paritally lled.
Fully Engaged Counter
Torque
Not Fully Engaged Counter
Torque

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SCREW EXTENSION REMOVAL
If Compression/Distraction is desired, do not remove screw head extensions and see steps on
page 21.
The Connection Tab and Screw Head Extensions protruding from the incisions must be re-
moved prior to completing the construct. First, the Connection Tab must be broken free of
the Screw Head. This can be achieved using the K-wire (CM-130-01) Gripper. Once the Tab is
gripped with the K-wire (CM-130-01) Gripper, rock the instrument superiorly/inferiorly to break
the Connection Tab away from each Screw Head. Discard each Connection Tab.
Once the Connection Tabs are removed, take the Screw Head Removal Tool (CM-136-01) and
engage each Screw Head Extension.

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Rotate the Screw Head Removal Tool
towards the center of the screw. Next,
rotate the Screw Head Removal Tool away
from the center of the screw. This order
of rotation leaves the smoothest screw
head surface. Repeat for both screw head
extensions on every screw in the construct.
Retrieve all screw head extensions and
discard.
Once all screw head extensions are removed, the construct is complete as shown below.