THEKEN VU MESH VBR SYSTEM

K070381 · Theken Spine, LLC · MQP · Apr 25, 2007 · Orthopedic

Device Facts

• Record ID: K070381
• Device Name: THEKEN VU MESH VBR SYSTEM
• Applicant: Theken Spine, LLC
• Product Code: MQP · Orthopedic
• Decision Date: Apr 25, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Theken VU MESH VBR System is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or otherwise unstable vertebral body due to tumor or trauma (i.e. fracture). The Theken VU MESH VBR System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. Bone graft material is recommended for packing into the interior opening of the device prior to implantation. The Theken VU MESH VBR System is intended for use with supplemental internal spinal fixation systems, such as the Theken BodyForm Thoracolumbar Fixation System (K983622, Approved 12/98) or the Theken Coral Pedicle Screw System (K041592, Approved 9/04).

Device Story

Theken Vu Mesh VBR is a spinal intervertebral body fixation orthosis; consists of square footprint polymer cages with axial and lateral fenestrations; features toothed endplates to engage neighboring vertebral bodies to resist rotation and migration. Device implanted individually or in pairs; always used with supplemental internal spinal fixation systems (e.g., pedicle screws). Interior opening packed with bone graft material to restore biomechanical integrity of anterior, middle, and posterior spinal columns. Used in surgical settings by orthopedic or neurosurgeons to treat spinal instability from tumor or trauma.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Materials: PolyEtherEtherKetone (PEEK OPTIMA LT) per ASTM F2026; Tantalum per ASTM F560. Design: Square footprint polymer cage with axial/lateral fenestrations and toothed endplates. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring replacement of a collapsed, damaged, or unstable vertebral body in the thoracolumbar spine (T1-L5) resulting from tumor or trauma (fracture). Must be used with supplemental internal spinal 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

• Theken Surgical L.LC Reveal VBR System (K050058)
• Surgical Titanium Mesh System (K003043)
• SynMesh Spacer System (K003275)
• Titanium Mesh (K032371)
• Curved PEEK Tetris™ (K041888)
• PEEK Tetris™ (K031757)

Reference Devices

• Theken BodyForm Thoracolumbar Fixation System (K983622)
• Theken Coral Pedicle Screw System (K041592)

Submission Summary (Full Text)

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### Theken Spine

### Vu Mesh VBR

2/1/2007

070381

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

#### A. Submitter Information

Submitter's Name: Address:

Telephone Number: Fax Number: Contact Person: Date Prepared:

Trade Name:

B. Device Information

Theken Spine 283 E. Waterloo Akron, Ohio 44319 330-773-7677 x221 330-773-7697 Dale Davison 16 January 2007

Theken Vu Mesh Vertebral Body Replacement (VBR)

toothed endplates engage with the superior and inferior endplates of the neighboring vertebral bodies to resist

individually or in a pair depending on the surgical need, however, the device is always implanted with the mesh cage

The Vu Mesh cage may be used

APR 2 5 2007

Common Name: Vertebral Body Replacement Device Classification Name: Spinal Intervertebral Body Fixation Orthosis (per 21 CFR 888.3060) Device Classification: Class II (per 21 CFR 888.3060) Panel: Orthopedic, Product Code: MQP, Panel Code: 87 Predicate Device: Theken Surgical L.LC Reveal VBR System (K050058) Comparative Devices: DePuy-AcroMed, Inc .- Surgical Titanium Mesh System (K003043) Synthes (USA)- SynMesh Spacer System (K003275) Encore Orthopedics, Inc. - Titanium Mesh (K032371) SIGNUS Medical LLC -Curved PEEK Tetris™ (K041888) SIGNUS Medical LLC - PEEK Tetris™ (K031757) Material Composition: PolyEtherEtherKetone (PEEK OPTIMA LT) per ASTM F2026. Tantalum per ASTM F560 Subject Device Description: The Theken Vu Mesh VBR system is comprised of square footprint polymer cages with fenestrations axially and laterally. It includes toothed endplates, which are used in combination with optional spacer components to extend the range of the cage in smaller increments. The cages, spacers and endplates can be assembled in a variety combinations to fit each individual patient's pathology. The

rotation and migration.

oriented vertically,

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of

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K070381/
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## Theken Spine

Intended Use:

#### Vu Mesh VBR

2/1/2007

The Theken VU MESH VBR System is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or otherwise unstable vertebral body due to tumor or trauma (i.e. fracture).

The Theken VU MESH VBR System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. Bone graft material is recommended for packing into the interior opening of the device prior to implantation.

The Theken VU MESH VBR System is intended for use with supplemental internal spinal fixation systems, such as the Theken BodyForm Thoracolumbar Fixation System (K983622, Approved 12/98) or the Theken Coral Pedicle Screw System (K041592, Approved 9/04).

#### Substantial Equivalence ে

The technological characteristics of the Theken Vu Mesh VBR SYSTEM are similar to the following predicate devices:

- REVEAL VBR System (K050058) manufactured by Theken Spine LLC and 1. cleared by the FDA on May 17, 2005.
- 2. Surgical Titanium Mesh System (K003043) manufactured by DePuy-AcroMed, Inc. and cleared by the FDA on May 8, 2001.
- 3. SynMesh Spacer System (K003275) manufactured by Synthes (USA) and cleared by the FDA on April 23, 2001.
- 4. Titanium Mesh (K032371) manufactured by Encore Orthopedics, Inc and cleared by the FDA on February 12, 2004
- Curved PEEK Tetris™ (K041888) manufactured by SIGNUS Medical LLC and ട്. cleared by the FDA on August 10, 2004.
- PEEK Tetris™ (K031757), manufactured by SIGNUS Medical LLC and cleared 6. by the FDA on July 3, 2003.

Establishment of equivalence is based on similarities of intended use, design, and physical characteristics. All implants are used to treat the same conditions, have essentially the same precautions and contraindications for use, and have equivalent potential for complications. Based on the design concept, the use of established well known materials, feature comparisons, mechanical testing, indications for use, pre-production quality assurance planning and engineering analysis, Theken Spine believes that sufficient evidence exists to reasonably conclude that the Vu Mesh VBR System is substantially equivalent to existing legally marketed devices.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular pattern around the symbol. The logo is black and white and appears to be a scanned image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Theken Spine c/o Mr. Dale Davison Vice President of Engineering 283 East Waterloo Road Akron, Ohio 44319

APR 2 5 2007

Re: K070381

Trade/Device Name: Vu Mesh VBR System Regulation Number: 21 CFR §888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: MQP Dated: March 30, 2007 Received: April 02, 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.

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Page 2 - Ms. Dale Davison

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.

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/industry/support/index.html.

Sincerely yours,

Barbara Buchup

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

Enclosure

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Theken Spine

Vu Mesh VBR

2/1/2007

# Indications for Use

510(k) Number (if known):

Device Name: Vu MESH VBR System

Indications For Use:

The Theken VU MESH VBR SYSTEM is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or otherwise unstable vertebral body due to tumor or trauma (i.e. fracture).

The Theken VU MESH VBR SYSTEM is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. Bone graft material is recommended for packing in the interior opening of the device prior to implantation.

The Theken VU MESH VBR SYSTEM is intended for use with supplemental internal spinal fixation systems, such as the Theken BodyForm Thoracolumbar Fixation System (K983622, Approved 12/98) or the Theken Coral Pedicle Screw System (K041592, Approved 9/04).

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

(21 CFR 801 Subpart C)

Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of __ 1

Barbave Buchm

Division Sion Division of General, Restorative. and Neurological Devices

510(k) Number_Ko 70381