BODYFORM THORACIC FIXATION SYSTEM

K072407 · Theken Spine, LLC · KWQ · Dec 21, 2007 · Orthopedic

Device Facts

• Record ID: K072407
• Device Name: BODYFORM THORACIC FIXATION SYSTEM
• Applicant: Theken Spine, LLC
• Product Code: KWQ · Orthopedic
• Decision Date: Dec 21, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BodyForm™ Thoracic Fixation System is intended as an adjunct to fusion for treatment of thoracic spinal instability as a result of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, spinal stenosis, deformities or curvatures (scoliosis, kyphosis, and/or lordosis), tumor, and anterior fusion following failed previous fusion operations, including pseudoarthrosis. The BodyForm™ Thoracic Fixation System is intended for unilateral use to attach to the anterolateral aspect of the vertebrah bodies at levels of fixation from T1 to L1.

Device Story

BodyForm™ Thoracic Fixation System consists of titanium alloy plates and screws; designed for unilateral, anterolateral fixation of thoracic spine (T1-L1). Device provides mechanical stabilization as adjunct to spinal fusion. Implanted by surgeons in clinical/OR setting. System stabilizes vertebral bodies to facilitate bone fusion; addresses instability from degenerative disease, trauma, deformity, or tumor. Benefits include structural support for spinal column during healing process.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: Medical grade titanium alloy Ti 6Al-4V (ELI) per ASTM F-136 and ISO 5832-3. Form factor: Plates and screws for anterolateral spinal fixation. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring thoracic spinal stabilization (T1-L1) due to degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, spinal deformities (scoliosis, kyphosis, lordosis), tumor, or failed previous fusion (pseudoarthrosis). Intended for unilateral anterolateral fixation.

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

• BodyForm™ Thoraco-Lumbar Fixation System, Theken Spine, LLC (K983622)
• Thoracolumbar Spine Locking Plate System, Synthes (K020244)
• Coral Spinal System, Theken Spine, LLC (K041592)

Submission Summary (Full Text)

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K072407

Theken Spine, LLC

BodyForm™ Thoracic Fixation System

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### 510(k) Summary (21 CFR Part 807.92)

Submitter Information A. Submitter's Name: Theken Spine, LLC Address: 283 E. Waterloo Akron, Ohio 44319 DEC 2 1 2007 Telephone Number: 330-773-7677 x221 Fax Number: 330-773-7697 Contact Person: Dale Davison Date Prepared: 8/21/07 Device Information B. BodyForm™ Thoracic Fixation System Trade Name: Anterior Spinal Fixation System Common Name: Classification: KWQ 888.3060 - Spinal Intervertebral Body Fixation Orthosis Predicate Device: BodyForm™ Thoraco-Lumbar Fixation System, Theken Spine, LLC (K983622) Thoracolumbar Spine Locking Plate System, Synthes (K020244) Coral Spinal System, Theken Spine, LLC (K041592) The purpose of this submission is for additional sizes of plates and Device Description: screws for the BodyForm™ Fixation System. This submission includes smaller sized plates and screws intended for the thoracic region of the spine. All implant components are manufactured from medical grade titanium alloy Ti 6Al-4V (ELI) per ASTM F-136. The BodyForm™ Thoracic Fixation System is intended as an Intended Use: adjunct to fusion for treatment of thoracic spinal instability as a result of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, spinal stenosis, deformities or curvatures (scoliosis, kyphosis, and/or lordosis), tumor, and anterior fusion following failed previous fusion operations, including pseudoarthrosis. The BodyForm™ Thoracic Fixation System is intended for unilateral use to attach to the anterolateral aspect of the vertebrah bodies at levels of fixation from T1 to L1. Implant grade titanium alloy Ti 6A1-4V (ELI) per ASTM F-136 Material Composition: and ISO 5832-3.

#### C. Substantial Equivalence

Theken Spine, LLC believes sufficient evidence exists to reasonably conclude that the BodyForm™ Thoracic Fixation System is substantially equivalent to other legally marketed predicate devices. This is based on the design concept, the use of established known materials, feature comparisons, mechanical testing, indications for use, and engineering analysis.

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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 consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 1 2007

Theken Spine, LLC % Mr. Dale Davison 283 E. Waterloo Akron. OH 44319

Re: K072407

Trade/Device Name: BodyForm™ Thoracic Fixation System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: December 17, 2007 Received: December 17, 2007

Dear Mr. Davison:

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 – Mr. Dale Davison

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Revorting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/industry/support/index.html.

Sincerely yours,

Mark M. Millman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# K072407

BodyForm™ Thoracic Fixation System Theken Spine, LLC

## Indications for Use

510(k) Number (if known):

The BodyForm™ Thoracic Fixation System is intended as an adjunct to fusion for treatment of thoracic spinal instability as a result of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, spinal stenosis, deformities or curvatures (scoliosis, kyphosis, and/or lordosis), tumor, and anterior fusion following failed previous fusion operations, including pseudoarthrosis.

The BodyForm™ Thoracic Fixation System is intended for unilateral use to attach to the anterolateral aspect of the vertebral bodies at levels of fixation from T1 to L1.

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

Over-The-Counter Use

(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Breech

Division of General, Restorative, and Neurologic ... Devices

510(k) **Number** K072407

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