SYNERGY HELICAL FLANGE PLUG, HELICAL FLANGE SEAT AND HELICAL FLANGE REDUCTION SEAT

K041449 · Interpore Cross Intl. · KWP · Jul 1, 2004 · Orthopedic

Device Facts

• Record ID: K041449
• Device Name: SYNERGY HELICAL FLANGE PLUG, HELICAL FLANGE SEAT AND HELICAL FLANGE REDUCTION SEAT
• Applicant: Interpore Cross Intl.
• Product Code: KWP · Orthopedic
• Decision Date: Jul 1, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Synergy Spinal System implants are intended to be used as a temporary construct that assists normal healing and are not intended to replace normal body structures. They are intended to stabilize the spinal operative site during fusion procedures and should be removed after fusion. The implants are attached to the spine posteriorly by means of hooks and/or screws joined with rods and anteriorly by means of vertebral screws joined with rods. As a pedicle screw system, the Synergy Spinal System is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the screws fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. The levels of screw fixation are L3 to S1/Ilium. In addition, the pedicle screw system may also be used to provide immobilization and stabilization of spinal segments, in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). As a posterior, non-pedicle, screw and hook system, and an anterolateral, intervertebral body screw system, the specific indications for the Synergy Spinal System are: Degenerative Disc Disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); Idiopathic scoliosis; Kyphotic deformities of the spine; Paralytic scoliosis and/or pelvic obliquity; Lordotic deformities of the spine; Neuromuscular scoliosis associated with pelvic obliquity; Vertebral fracture or dislocation; Tumors; Spondylolisthesis; Stenosis; Pseudarthrosis; Unsuccessful previous attempts at spinal fusion. For posterior, non-pedicle, screw use, the Synergy screws and lateral connectors are intended for sacral/iliac attachment only, and the Synergy hooks and transverse connectors are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use are T1 to the Sacrum/Ilium. The Adjustable Length Rod is intended for in situ adjustment after placement of the hooks or screws during spinal fusion surgery. For anterior use, the recommended levels of attachment are: T10 to L3 for the double rod constructs and T5 to L5 for the single rod constructs. The 4.75 mm diameter rod system can be used in single and double rod constructs while the 6.35 mm diameter rod system is to only be used in single rod constructs. In all cases, instrumentation must be at least 1 cm from any major vessel.

Device Story

Synergy Spinal System; temporary spinal fixation construct; assists healing during fusion. Components: screws (pedicle, variable locking, iliac), hooks, rods (including adjustable length), transverse/lateral connectors, vertebral washers. Posterior application: hooks/screws/rods (T1-Sacrum/Ilium). Anterior application: vertebral screws/rods (T5-L5). Adjustable length rod allows in situ distraction after anchor placement. Used by surgeons in OR; provides immobilization/stabilization of spinal segments. Benefits: stabilizes operative site; facilitates fusion; allows correction of deformities/instabilities. Instrumentation requires 1cm clearance from major vessels.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, materials, and biomechanical performance.

Technological Characteristics

Spinal fixation system; components include screws, hooks, rods, and connectors. Materials: unspecified metallic spinal implant materials. Energy source: none (mechanical). Connectivity: none. Sterilization: provided via sterilizer cases. Form factor: modular rod-screw/hook system with 4.75mm and 6.35mm rod diameters.

Indications for Use

Indicated for skeletally mature patients requiring spinal stabilization/immobilization as an adjunct to fusion. Conditions: severe spondylolisthesis (L5-S1), degenerative disc disease, idiopathic/paralytic/neuromuscular scoliosis, kyphotic/lordotic deformities, vertebral fracture/dislocation, tumors, stenosis, pseudarthrosis, failed previous fusion. Contraindications: not for use replacing normal body structures; requires removal after fusion; pedicle screw use restricted to L3-S1/Ilium with autogenous bone graft.

Regulatory Classification

Identification

A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.

Submission Summary (Full Text)

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#### JUL - 1 2004 510(k) SUMMARY

### SUBMITTED BY

Wendy Spielberger Lead Regulatory and Clinical Affairs Staff INTERPORE CROSS International 181 Technology Drive Irvine, California 92618

[phone]

May 28, 2004

This summary of 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR §807.92.

## CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME

Spinal Intervertebral Body Fixation Orthosis Classification Name: Common/Usual Name: Anterior and Posterior Spinal Implants Product Classification: Class II Synergy™ Spinal System Proprietary Name:

### PREDICATE DEVICE

Predicate device information is included in this premarket notification.

### INDICATIONS-FOR-USE

The Synergy Spinal System implants are intended to be used as a temporary construct that assists normal healing and are not intended to replace normal body structures. They are intended to stabilize the spinal operative site during fusion procedures and should be removed after fusion.

The implants are attached to the spine posteriorly by means of hooks and/or screws joined with rods and anteriorly by means of vertebral screws joined with rods.

As a pedicle screw system, the Synergy Spinal System is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the screws fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. The levels of screw fixation are L3 to S1/Ilium.

In addition, the pedicle screw system may also be used to provide immobilization and stabilization of spinal segments, in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

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# Synergy™ Spinal System

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As a posterior, non-pedicle, screw and hook system, and an anterolateral, intervertebral body screw system, the specific indications for the Synergy Spinal System are:

- 1. Degenerative Disc Disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
- 2. Idiopathic scoliosis.
- Kyphotic deformities of the spine. 3.
- Paralytic scoliosis and/or pelvic obliquity. বা
- న. Lordotic deformities of the spine.
- Neuromuscular scoliosis associated with pelvic obliquity. 6.
- Vertebral fracture or dislocation. 7.
- 8. Tumors.
- 9. Spondylolisthesis.
- 10. Stenosis.
- 11. Pseudarthrosis.
- 12. Unsuccessful previous attempts at spinal fusion.

For posterior, non-pedicle, screw use, the Synergy screws and lateral connectors are intended for sacral/iliac attachment only, and the Synergy hooks and transverse connectors are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use are T1 to the Sacrum/lium.

The Adjustable Length Rod is intended for in situ adjustment of the hooks or screws during spinal fusion surgery.

For anterior use, the recommended levels of attachment are: T10 to L3 for the double rod constructs and T5 to L5 for the single rod constructs. The 4.75 mm diameter rod system can be used in single and double rod constructs while the 6.35 mm diameter rod system is to only be used in single rod constructs. In all cases, instrumentation must be at least 1 cm from any major vessel.

## DEVICE DESCRIPTION

The Synergy™ Spinal System components are grouped as follows:

## Posterior Application:

- Integral™ Open, Closed, Angled Closed and Reduction Screws, Variable Locking Screws with 1. Variable Locking Seats and Iliac Screws with Hex Nuts and Set Screws. Caution: Only the Integral™ Open, Closed, Reduction and Variable Locking Screws are intended for pedicle fixation.
- Open and Closed Spinal Hooks with Sliders, C-rings and Set Screws. 2.
- Adjustable and Fixed Transverse Connectors with Set Screws. 3.
- 4. Closed and Axial Rod Connectors with Set Screws.
- Lateral Connectors with Set Screws. న్.
- Rods and Adjustable Length Rods and Set Screws. 6.
- 7. Instruments.
- 8. Sterilizer case(s).

## Anterior Application:

- 1. Integral™ Open and Closed Screws and Variable Locking Screws with Variable Locking Seats, with Hex Nuts and Set Screws.
- 2. Vertebral Washers.
- 3. Fixed Transverse Connectors with Set Screws.

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- 4. Rods.
- 5. Instruments.
- 6. Sterilizer case(s).

NOTE: While the Variable Locking Screws and some fasteners (nuts and set screws) are used for both the 6.35mm and 4.75mm rod sizes, the remaining components (except for those connector components that are designed to join the two rod sizes) are designed for specific rod diameters.

NOTE: The Adjustable Length Rod is intended for in situ adjustment after placement of the hooks or screws during spinal fusion surgery.

The Adjustable Length Rod is intended for use as part of either a single or double rod assembly. The Adjustable Length Rod allows for distraction at a central location once the bone anchors have been secured.

## COMPARISON TO THE PREDICATE DEVICE

Based on the same indications for use, intended use, similarity in materials of construction and equivalent biomechanical performance, the Synergy Spinal System is considered substantially equivalent to the legally marketed predicate device.

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Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a bird-like figure.

JUL - 1 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Wendy Spielberger Lead Regulatory and Clinical Affairs Staff Interpore Cross International 181 Technology Drive Irvine, California 92618-2402

Re: K041449

Trade/ Device Name: Synergy™ Helical Flange Plug, Seat, and Reduction Seat Regulation Numbers: 21 CFR 888.3050, 21 CFR 888.3060, 21 CFR 888.3070(b)(1) Regulation Names: Spinal interlaminal fixation orthosis, Spinal intervertebral body fixation orthosis. Pedicle screw spinal system

Regulatory Class: II Product Codes: KWP, KWQ, MNH Dated: May 28, 2004 Received: June 1, 2004

Dear Ms. Spielberger:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Wendy Spielberger

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Miriam C. Provost

for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

# 510(k) Number (if known): K041449

#### Synergy Helical Flange Plug, Seat, and Reduction Seat Device Name:

### Indications-For-Use:

The Synergy Spinal System implants are intended to be used as a temporary construct that assists normal healing and are not intended to replace normal body structures. They are intended to stabilize the spinal operative site during fusion procedures and should be removed after fusion.

The implants are attached to the spine posteriorly by means of hooks and/or screws joined with rods and anteriorly by means of vertebral screws joined with rods.

As a pedicle screw system, the Synergy Spinal System is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (LS-S1) vertebral joint; (b) who acc receiving fusions using autogenous bone graft only; (c) who are having the screws fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. The levels of screw fixation are L3 to SI/Ilium.

In addition, the pedicle screw system may also be used to provide immobilization and stabilization of spinal segments, in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

As a posterior, non-pedicle, screw and hook system, and an anterolateral, intervertebral body screw system, the specific indications for the Synergy Spinal System are:

- Degenerative Disc Disease (as defined by chronic back pain of discogenic origin with し、 degeneration of the disc confirmed by history and radiographic studies).
- Idiopathic scoliosis. 2.
- Kyphotic deformities of the spine. 3.
- Paralytic scoliosis and/or pelvic obliquity. ব .
- Lordotic deformities of the spine. న్న
- Neuromuscular scoliosis associated with pelvic obliquity. ర్.
- Vertebral fracture or dislocation. 7.
- Tumors. 8.
- Spondylolisthesis. ರು.
- Stenosis. 10.
- Pseudarthrosis. 11.
- Unsuccessful previous attempts at spinal fusion. I 2.

(continued)

Page 1 of 2

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## Indications for Use (continued)

### 510(k) Number (if known): K041449

#### Synergy Helical Flange Plug, Seat, and Reduction Seat Device Name:

#### Indications-For-Use (cont'd):

For posterior, non-pedicle, screw use, the Synergy screws and lateral connectors are intended for sacral/illiac attachment only, and the Synergy hooks and transverse connectors are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use are T1 to the Sacrum/Ilium.

The Adjustable Length Rod is intended for in situ adjustment after placement of the hooks or screws during spinal fusion surgery.

For anterior use, the recommended levels of attachment are: T10 to L3 for the double rod constructs and TS to L5 for the single rod construct. The 4.75 mm diameter rod system can be used in single and double rod constructs while the 6.35 mm diameter rod system is to only be used in single rod constructs. In all cases, instrumentation must be at least 1 cm from any major vessel.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use_ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

Page 2 of 2

Division of General, Restorative, and Neurological Devices

**510(k) Number** K641449