BODYFORM THORACO-LUMBAR FIXATION SYSTEM

K983622 · Theken Surgical,Llc · KWQ · Dec 30, 1998 · Orthopedic

Device Facts

• Record ID: K983622
• Device Name: BODYFORM THORACO-LUMBAR FIXATION SYSTEM
• Applicant: Theken Surgical,Llc
• Product Code: KWQ · Orthopedic
• Decision Date: Dec 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BodyForm Thoraco-Lumbar Fixation System is intended for treatment of anterior thoraco-lumbar spinal instability caused by: 1. Trauma. 2. Tumor. 3. Degenerative Disc Disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. 4. Anterior fusion following multiple failed posterior fusion operations, including pseudoarthrosis. The instrumentation is designed for levels of fixation from T10 to L4.

Device Story

BodyForm Thoraco-Lumbar Fixation System is a spinal orthosis construct; consists of one plate contoured to lateral profile of thoraco-lumbar vertebral bodies, four Morse taper headed screws, and two locking set screws. Plates are sized to specific graft heights. Device is used by surgeons in clinical settings to provide anterior spinal fixation. System stabilizes spine to treat instability from trauma, tumor, DDD, or failed prior fusion. Benefits include structural support for spinal fusion.

Clinical Evidence

Bench testing only. Stiffness, strength, and fatigue life characterized per ASTM F-1717-96.

Technological Characteristics

Construct includes plate, Morse taper headed screws, and locking set screws. Materials not specified beyond general system description. Designed for T10-L4 fixation. Mechanical fixation principle.

Indications for Use

Indicated for patients requiring anterior thoraco-lumbar spinal stabilization (T10-L4) due to trauma, tumor, degenerative disc disease (discogenic back pain confirmed by history/radiography), or anterior fusion following failed posterior fusion/pseudoarthrosis.

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

Predicate Devices

• Z-Plate Anterior Fixation System (Sofamor-Danek)
• University Plate Titanium Anterior System (Acromed)
• Anterior Thoracolumbar Locking Plate (Synthes)

Submission Summary (Full Text)

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30 1998

K983622

# BodyForm™ Thoraco-Lumbar Fixation System

510 (k) Summary

- Company: Theken Surgical 1100 Nola Avenue Barberton, Ohio 44203
#### BodyForm™ Thoraco-Lumbar Fixation System Trade Name:

Classification: Spinal Intervertebral Body Fixation Orthosis. Class II,

The BodyForm™ Thoraco-Lumbar Fixation System is a construct which consists Description: of one plate, contoured to match the lateral profile of the thoraco-lumbar vertebral bodies, four Morse taper headed screws, and two locking set screws. Plates are designed specifically to particular graft heights, with anatomic limitations in mind.

### Performance Data:

Non-clinical:

Testing was conducted according to ASTM F-1717-96. Properties of stiffness, strength, and fatique life were characterized.

### Intended Use:

The BodyForm Thoraco-Lumbar Fixation System is intended for treatment of anterior thoraco-lumbar spinal instability caused by:

- 1. Trauma.
- 2. Tumor.
- Degenerative Disc Disease (DDD). DDD is defined as back pain of ల discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
- ব Anterior following multiple failed posterior fusion operations, including pseudoarthrosis,

The instrumentation is designed for levels of fixation from T10 to L4.

### Substantial Equivalence:

Z-Plate Anterior Fixation System (Sofamor-Danek) University Plate Titanium Anterior System (Acromed) Anterior Thoracolumbar Locking Plate (Synthes)

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three abstract human profiles facing right, layered on top of each other, creating a sense of depth and connection.

## DEC 30 1998

Mr. Lukas Eisermann Director, Regulatory Affairs Theken Surgical 1100 Nola Avenue Barberton, Ohio 44203

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K983622

Trade Name: BodyForm Thoraco-Lumbar Fixation System Regulatory Class: II Product Code: KWQ Dated: October 13, 1998 Received: October 15, 1998

Dear Mr. Eisermann:

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 Quality System Regulation (QS) 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.

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.

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Page 2 - Mr. Eisermann

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 vours.

Thurell T. Hayes

C.L.M. Witt, Ph.D., M.D.

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

Enclosure

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DEC-20-20 00 . DEFFLEFF

510(k) Number K983622. Revision C. Decenber 1998.

### 510 (k) Number (if known): K983622

### Device Name: BodyForm™ Thoraco-Lumbar Fixation System

- 1. Indications for Use:
The BodyForm Thoraco-Lumbar Fixation System is intended for treatment of anterior thoraco-lumbar spinal instability caused by:

- 1. Trauma.
- 2. Tumor.
- 3. Degenerative Disc Disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies,
- 4. Anterior fusion following multiple failed posterior fusion operations, including pseudoarthrosis.

The instrumentation is designed for levels of fixation from T10 to L4.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (per 21 CFR 801.109)

OR

Over-The-Counter Use __

(Oplional Format 1/2/96)

Thos. S. Page for Com.

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