SILHOUETTE SPINAL FIXATION SYSTEM

K993067 · Sulzer Spine-Tech · KWP · Nov 16, 1999 · Orthopedic

Device Facts

• Record ID: K993067
• Device Name: SILHOUETTE SPINAL FIXATION SYSTEM
• Applicant: Sulzer Spine-Tech
• Product Code: KWP · Orthopedic
• Decision Date: Nov 16, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When used as a pedicle screw fixation system in skeletally mature patients, the system is intended to provide immobilization and stabilization of spinal segments 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, spinal tumor, and failed previous fusion (pseudarthrosis). In addition, when used as a pedicle screw fixation system, the Silhouette™ Spinal Fixation System is indicated for use in patients: - having severe spondylolisthesis (Grade 3 and 4) at the L5-S1 joint - who are receiving fusions with autogenous graft only - who are having the device fixed or attached to the lumbar or sacral spine, and - who are having the device removed after the development of a solid fusion mass. When used as a hook and sacral screw system, the Silhouette™ Spinal Fixation System is intended for use in the treatment of 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, spondylolisthesis, kyphotic or lordotic deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal fusion. When used for this indication, screws of the Silhouette™ Spinal Fixation System are intended for sacral iliac attachment only. Hook and transverse connectors of the system are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use for hook and sacral screw fixation of this system are T1 to the sacrum.

Device Story

Temporary posterior spinal fixation system; consists of polyaxial/fixed screws, rods, hooks, and transverse connectors. Used in thoracic, lumbar, and sacral spine (T1-sacrum). Implants provide immobilization and stabilization to facilitate biological spinal fusion. Components are top-loading and top-tightening. Intended for removal after solid fusion. Used by surgeons in clinical settings. Benefits include correction of spinal deformity and stabilization of unstable segments.

Clinical Evidence

Bench testing only. Fatigue testing of the adjustable transverse connector construct was performed per ASTM Provisional Standard PS 5-94 (Static and Dynamic Spinal Implant Assembly in a Corpectomy Model). Results showed no failures at 156 N run-out load for 5,000,000 cycles.

Technological Characteristics

Titanium alloy (Ti-6Al-4V) per ASTM F-136. System includes polyaxial/fixed screws, rods, hooks, and transverse connectors. Top-loading/top-tightening mechanism. Mechanical fixation device; no energy source or software.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization/stabilization as an adjunct to fusion for thoracic, lumbar, and sacral spine instabilities/deformities including degenerative spondylolisthesis, fracture, dislocation, scoliosis, tumor, and pseudarthrosis. Also indicated for severe spondylolisthesis (Grade 3-4) at L5-S1, degenerative disc disease, and spinal stenosis. Contraindicated for patients not receiving autogenous graft or those not requiring device removal post-fusion.

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.

Predicate Devices

• Silhouette™ Spinal Fixation System (K992276)

Submission Summary (Full Text)

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Image /page/0/Picture/3 description: The image shows the words "SULZER MEDICA" in a bold, sans-serif font. The text is black and appears to be a logo or brand name. The words are arranged horizontally, with "SULZER" above "MEDICA".

NOV 1 6 1999

1.493067

Sulzer Spine-Tech

7375 Bush Lake Road Minneapolis, MN 55439-2027

Phone [phone] Fax

## 510(k) Summary

| A. | Submitters' Information | |
|----|----------------------------------|-------------------------------------------------------------------------------------|
| | Date: | November 15, 1999 |
| | Name/Address: | Sulzer Spine-Tech<br>7375 Bush Lake Road<br>Minneapolis, Minnesota 55439 |
| | Telephone Number:<br>Fax Number: | [phone]<br>[phone] |
| | Contact: | Janell A. Colley<br>Regulatory Affairs Specialist |
| B. | Device Information | |
| | Trade Name: | Silhouette™ Spinal Fixation System |
| | Common Name: | Rod, hook, and screw spinal<br>instrumentation |
| | Classification: | Class II, KWP, MNI, and MNH |
| | Predicate Device: | Silhouette™ Spinal Fixation System<br>K992276<br>(concurrence date October 1, 1999) |

## Device Description:

The Silhouette™ Spinal Fixation System is a temporary implant system used to correct spinal deformity and to facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic, lumbar, and sacral areas of the spine. Implants in this system consist of hooks and/or screws connected to rods that are intended to be removed after solid fusion has occurred. The system includes polyaxial screws of varving diameters and lengths, fixed screws of varying diameters and lengths, rods in varying lengths, hooks in varying designs, and transverse connectors in fixed and adjustable widths. All implant components are top loading and top tightening. The implants in this system are manufactured from titanium alloy (Ti-6A1-4V) that conforms to ASTM F-136.

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# Intended Use:

When used as a pedicle screw fixation system in skeletally mature patients, the system is intended to provide immobilization and stabilization of spinal segments 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, spinal tumor, and failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the Silhouette™ Spinal Fixation System is indicated for use in patients:

- having severe spondylolisthesis (Grade 3 and 4) at the L5-S1 ೩) joint
- who are receiving fusions with autogenous graft only b)
- who are having the device fixed or attached to the lumbar or c) sacral spine, and
- d) who are having the device removed after the development of a solid fusion mass

When used as a hook and sacral screw system, the Silhouette™ Spinal Fixation System is intended for use in the treatment of 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, spondylolisthesis, kyphotic or lordotic deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal fusion. When used for this indication, screws of the Silhouette™ Spinal Fixation System are intended for sacral iliac attachment only. Hook and transverse connectors of the system are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use for hook and sacral screw fixation of this system are T1 to the sacrum.

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#### C. Comparison of Required Technological Characteristics

The modified Silhouette™ Spinal Fixation System is substantially equivalent to the predicate Silhouette™ Spinal Fixation System. The table below provides a comparison of equivalency characteristics.

| Characteristics | Equivalency |
|-----------------------------------|--------------------------|
| Intended Use | Identical |
| Anatomical Sites | Identical |
| Target Population | Identical |
| Sterilization | Identical |
| Packaging | Identical |
| Operating Principle | Identical |
| Materials | Identical |
| Labeling | Substantially Equivalent |
| Physical Characteristics (Design) | Substantially Equivalent |
| Performance Testing | Substantially Equivalent |
| Safety Characteristics | Substantially Equivalent |

#### D. Summary of Non-Clinical Tests

The following is a summary of the testing performed on the modified Silhouette™ Spinal Fixation System:

| Modification | Test Performed | Acceptance<br>Criteria | Test Results |
|------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|--------------|
| Addition of<br>Adjustable<br>Transverse<br>Connector | Fatigue Testing of Silhouette™<br>Spinal Fixation<br>System/adjustable transverse<br>connector construct per ASTM<br>Provisional Standard PS 5-94,<br>Test Method for Static and<br>Dynamic Spinal Implant<br>Assembly in a Corpectomy<br>Model | No Failures<br>156 N run-out<br>load<br>5,000,000 cycles | Passed |

#### Conclusions Drawn From Testing E.

Testing of the modified Silhouette™ Spinal Fixation System demonstrates that the device is substantially equivalent to the predicate Silhouette™ Spinal Fixation System and that the design modifications do not affect device safety and effectiveness

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its body and wings. The bird is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is written around the border of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 6 1999

Ms. Janell A. Colley Regulatory Affairs Specialist Sulzer Spine-Tech 7375 Bush Lake Road Minneapolis, Minnesota 55439-2027

Re: K993067

> Trade Name: Silhouette™ Spinal Fixation System Regulatory Class: II Product Codes: KWP, MNH and MNI Dated: October 21, 1999 Received: October 22, 1999

Dear Ms. Colley:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Ouality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Janell A. Colley

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### INDICATIONS FOR USE STATEMENT

510(K) Number: K993067

Silhouette™ Spinal Fixation System Device Name:

Indications for Use:

When used as a pedicle screw fixation system in skeletally mature patients, the Silhouette™ Spinal Fixation System is intended to provide immobilization of spinal segments 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, spinal tumor, and failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the Silhouette™ Spinal Fixation System is indicated for use in patients:

- having severe spondylolisthesis (Grade 3 and 4) at the LS-S1 joint a)
- who are receiving fusions with autogenous graft only b)
- who are having the device fixed or attached to the lumbar or sacral spinc, and c)
- d) who are having the device removed after the development of a solid fusion mass

When used as a hook and sacral screw system, the Silhouette™ Spinal Fixation System is intended for use in the treatment of 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, spondylolisthesis, kyphotic or lordotic deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal fusion. When used for this indication, screws of the Silhouette™ Spinal Fixation System are intended for sacral iliac attachment only. Hook and transverse connectors of the system are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use for hook and sacral screw fixation of this system are T1 to the sacrum.

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

### Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

AR colep B

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K993067

**Prescription Use**
**(Per 21 CFR 801.109)**

Over-the-Counter-Use