ISSYS LP SP I n a L FI xat I on YS tem Su r g I c a L gu I d...

ISSYS LP SPInaL FIxatIon SYStem

SurgIcaL guIde

Y o u r I d e a S e n g I n e e r e d t o L I F e

IntroductIon

ISSYS LP SPInaL FIxatIon SYStem The foundation of the ISSYS LP Spinal Fixation System is the ISSYS LP Polyaxial Screw which incorporates a number of innovative design features.

Blocker• Coarse 0° buttress thread design is easy to start and helps

minimize cross-threading.

Saddle Pin• Unique design accommodates 5.5mm, 6.0mm and 6.35mm

rod diameters.

• Hemi-circumferential contact uniformly distributes locking forces without notching the rod.

• Five independent locking forces make ISSYS LP one of the stiffest and strongest systems on the market.

Screw Head• 6.4mm of medial-lateral translation provides the surgeon

added flexibility for screw placement.

• Low profile design allows close proximity screw placement.

Bone Screw• Designed to be completely seated for added stability while

maintaining full polyaxial motion.

• Double-lead buttress thread provides for faster insertion with exceptional purchase.

• Thread design engineered for optimum strength.

Other Features• Patent pending Screwdriver with one-step, toggle free con-

nection.

• Unique instrument for one-handed rod reduction and blocker insertion.

• Ratcheting Torque Wrench for prescribed tightening torque.

• All implant components are made from Ti6Al4V.

• MIS compatible system.

ASTM test results on file at Custom Spine

PedIcLe PreParatIon 1

Screw InSertIon 2

rod PreParatIon 3

BLocker InSertIon 4

VerteBraL BodY dIStractIon and comPreSSIon 6

FInaL tIghtenIng 7

SYStem InFormatIon 8 IndIcatIons contraIndIcatIons cautIons

ImPLantS 10

InStrumentS 12

taBLe oF contentS

Upon identifying the pedicle entry point, the Pedicle Probe is used to penetrate the near cortex of the pedicle. A pathway is created with the Pedicle Probe. The Pedicle Probe is marked in 10.0mm increments to assist with depth insertion.

The Pedicle Sounder is used to verify the integrity of the pedicle wall.

The Rasp should be inserted into the pedicle pathway to create a recess for the ISSYS LP Polyaxial Screw.

Attach the appropriate diameter Tap to the Ratchet Round Handle to prepare the canal for screw insertion.The ISSYS LP is a self-tapping screw. It is recommended to tap hard bone. If tapping is necessary attach the appropriate diameter Tap (4.5mm, 5.5mm, 6.5mm, 7.5mm, 8.5mm) to the Round Ratchet Handle. The taps are calibrated in 10mm increments.

PedIcLe PreParatIon

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1

3 4

2

IMPORTANT: After determining the appropriate screw diameter, always measure the screw to en-sure screw length.

Attach the Screwdriver to the Ratchet Round Handle by retracting the quick coupler on the Handle. If you do not feel a positive click, gently rotate the handle.

Pinch the arm on the shaft of the Screwdriver and push down on the coupler located on proximal screwdriver shaft to secure the screw.

Insert the distal tip of the Screwdriver into the saddle of the screw head until the “claws” engage the dimples of the screw. If the Screwdriver does not engage the screw gently rotate the threaded portion of the screw.

It is always recommended to insert the pedicle screw as deep as the anatomy allows.

Screw InSertIon

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1 2

3 4

Once all pedicle screws are inserted, it is recommended that the Rod Template be used to determine the Rod length and curvature.

Once the Rod is contoured, the Rod Holder is used to insert the Rod. The Rod Holder functions two ways; the Rod Holder may clamp down on the shaft of the rod.

Use the In-situ Bender or the French Bender to contour the appropriate Rod.

The rod may be inserted by connecting the pins of the rod holder. This is particularly useful when using a Minimally Invasive Surgical approach.

rod PreParatIon

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1 2

3 4

The ISSYS LP offers two options for Blocker insertion:

Option 1:

Attach the Blocker Inserter to the Round Ratchet Handle.

If the rod is slightly proud with respect to the screw head, the Rocker can be used to lever the Rod into the Screw Head Saddle. The Rocker can be aligned into the holes on the side of the Screw Head and rotated back which will lever the rod into position.

With the Rocker in place, the Blocker is inserted with the Blocker Inserter until snug. At this point the blocker is ready for final-tightening. Do not over tighten the Blocker Inserter. See Final Tightening.

Option 2:

TIP: In either option, make sure the rod is fully seated in the screw head before attempting to insert the Blocker. This will help avoid false locking or cross-threading.

The Rod Reducer may be used when additional force is needed to bring the Screw Head up to the Rod.

Prior to inserting the rod reducer over the Screw Head, the instrument must be completely opened.

In position “0” the Rod Reducer is completely open and inserted over the Screw Head until the tangs on the distal tip of the Rod Reducer engage the grooves on the side of the Screw Head.

BLocker InSertIon

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1 1

2

2

3

Rotate the knob clockwise to position “1”. The Rod Reducer is now firmly locked to the screw head.

Load the Blocker onto the Blocker inserter and insert through the cannula of the Rod Reducer.

At this point the Blocker is ready for final-tightening. See Final Tightening.

Rotate the knob clockwise to position “2” for full reduction. At this point, the rod is now optimally seated and the instrument is ready to accept the Blocker.

Advance the Blocker until the bottom of the knurl on the Blocker Inserter is aligned with the top edge of the Rod Reducer.

The rod reducer must be completely opened prior to removal by rotating the knob counter clockwise to position “0”. At this point, the Rod Reducer can easily be lifted from the screw head.

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3 4

6

7 8

5

DISTRACTION

The ISSYS LP Distractor and Compressor will allow the surgeon to control and apply distraction and compression to the vertebral bodies. To achieve distraction, one of the Blockers is tightened while the adjacent level Blocker is not tightened. The Distractor is placed onto the Rod between the screw heads and distraction is achieved by “squeezing” the Distraction Handles.

The Blocker is then tightened while maintaining distraction. Final Tightening is achieved using the Counter-Torque Wrench and Torque Wrench. See Final Tightening.

COMPRESSION

To achieve compression, one of the Blockers is tightened, while the adjacent level Blocker is not tightened.

The Compressor is placed onto the Rod outside the screw heads and compression is achieved by “squeezing” the Compressor Handles.

The Blocker is then tightened while maintaining distraction. Final Tightening is achieved using the Counter-Torque Wrench and Torque Wrench. See Final Tightening.

VerteBraL BodY dIStractIon and comPreSSIon

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FInaL tIghtenIng

The Torque Wrench has four groups of three arrows located around the top of the instrument, which provide visual assistance for determining the prescribed tightening torque. Prior to applying leverage, the top arrow in each group will be aligned with the bottom right arrow. Apply leverage until the top arrow is aligned with the bottom left arrow. Once the two said arrows are aligned, the prescribed tightening torque has been applied to the Blocker.

NOTE: Exceeding the prescribed tightening torque by over levering the arrows past the final alignment can damage the implant and or instrument.

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1

SYStem InFormatIon

NON STERILE PRODUCT

The Custom Spine ISSYS LP Spinal Fixation System is comprised of spinal implants for fixation of the non-cervical spine. This includes: rods, screws and blockers. The components are manufactured from titanium alloy. The screws are available in various sizes from 4.5mm to 10.0mm diameters with lengths ranging from 25mm to 100mm.

MATERIALS

Titanium alloy: Ti6-Al-4V according to ISO 5832-3, ASTM F-136

(NOTE: Titanium and stainless steel implants should not be mixed in patients as corrosion may occur resulting in decreased mechanical performance)

INDICATIONS

The FDA regulation restricts the use of pedicle screw fixation as follows:

For pedicular use: When used as a pedicle screw fixation system of the non- cervical posterior spine in skeletally mature patients, these systems are indicated for one or more of the following: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

In addition, this system is indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (grade 3 & 4) at the L5-S1 joint having fusion with autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below) with removal of the implants after the development of a solid fusion mass.

When used as non pedicular fixation system: The ISSYS LP Spinal Fixation Systems, when used as an anterior screw fixation system and posterior sacraliliac screw fixation system are indicated for the following:

• Degenerative disc disease (DDD) of the thoracic and lumbar spine (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).

• Spondylolisthesis

• Fracture

• Spinal deformities such as scoliosis, kyphosis, lordosis

• Tumor

• Revision of failed fusion attempts

• Pseudarthrosis

• Spinal stenosis

When used in the anterior indication the ISSYS LP Spinal Fixation Systems are indicated for use in the thoracic and lumbar spine.

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CONTRAINDICATIONS

Contraindications may be relative or absolute. The choice of a particular device must be carefully weighed against the patient’s overall evaluation. Circumstances listed below may reduce the chances of a successful outcome:

• Any abnormality present which affects the normal process of bone remodeling including, but not limited to, severe osteoporosis involving the spine, active infection at the site or certain metabolic disorders affecting osteogenesis.

• Insufficient quality or quantity of bone which would inhibit rigid device fixation.

• Previous history of infection.

• Excessive local inflammation.

• Open wounds.

• Any neuromuscular deficit which places an unusually heavy load on the device during the healing period.

• Obesity. An overweight or obese patient can produce loads on the spinal system which can lead to failure of the fixation of the device or to failure of the device itself.

• Patients having inadequate tissue coverage of the operative site.

• Pregnancy.

• A condition of senility, mental illness, or substance abuse. These conditions, among others, may cause the patient to ignore certain necessary limitations and precautions in the use of the implant, leading to failure or other complications.

• Foreign body sensitivity. Where material sensi-tivity is suspected, appropriate tests should be made prior to material selection or implantation.

• Other medical or surgical conditions which would preclude the potential benefit of spinal implant surgery, such as the presence of tumors, congenital abnormalities, elevation of sedimentation rate unexplained by other diseases, elevation of white blood cell count (WBC), or marked left shift in the WBC differential count.

These contraindications can be relative or absolute and must be taken into account by the physician when making his decision. The above list is not exhaustive.

CAUTION: Federal law (U.S.A.) restricts this device to sale by or on the order of a licensed physician.

Pedicle Screw implantation should only be performed by experienced spinal surgeons with specific training in the use of the ISSYS LP Spinal Fixation System. This is a technically demanding procedure with a risk of serious patient injury.

The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to spondylolisthesis (grades 3 and 4) of the L5-S1 vertebrae, degenerative spondylolisthesis with objective evidence of neurological impairment, fracture dislocation, scoliosis, kyphosis, spinal tumor, and failed pervious fusion. (Pseudoarthrosis) The safety and effectiveness of these devices for any other conditions are unknown.

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Catalog # Description Notes

043000 ISSYS LP Blocker Screw

046040 ISSYS LP Spinal Rod 6.0x40

Pre-bent






Straight








Pre-bent






Straight







ImPLantS

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044525 ISSYS LP Spinal Screw Polyaxial 4.5x25

Non self-tapping







Self-tapping






















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4.5mm

5.5mm

6.5mm

7.5mm

8.5mm

InStrument oVerVIew

Catalog # Description

049000 Rasp

049001 Pedicle Probe

049002 5.5mm Tap

049003 6.5mm Tap

049004 7.5mm Tap

049005 8.5mm Tap

049006 Screwdriver

049007 Rod Holder

049008 Rod Pusher

049009L In-situ Bender Left

049009R In-situ Bender Right

049010 Compressor

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049011 Distractor

049012 Blocker Inserter

049013Counter-Torque Wrench

049014 Revision Driver

049015 Torque Wrench

019001N Narrow Pedicle Probe

019002 Pedicle Sounder

019004 4.5mm Tap

019009SR Ratchet Handle

019012 Rod Template

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049017 Rod Reducer

049016 Cam-Coupler

019016 Rocker

019017 Rod Gripper

019018 French Bender

019029 Tap Sleeve

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Tel: (973) 808-0019Fax: (973) 808-0707

1140 ParsiPPany Blvd., suiTe 201ParsiPPany, nJ 07054

www.customspine.com

Product Number: 000201 REV A

ISSYS LP SP I n a L FI xat I on YS tem Su r g I c a L gu I d...

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