THEKEN REVEAL VBR SYSTEM

K050058 · Theken Surgical,Llc · MQP · May 17, 2005 · Orthopedic

Device Facts

• Record ID: K050058
• Device Name: THEKEN REVEAL VBR SYSTEM
• Applicant: Theken Surgical,Llc
• Product Code: MQP · Orthopedic
• Decision Date: May 17, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Theken VU VBR SYSTEM is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (e.g., fracture). The Theken VU VBR SYSTEM is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absences of fusion for a prolonged period. Bone graft material is recommended to be packed into the interior openings of the device prior to implantation. The Theken VU VBR SYSTEM is intended to be used 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 VBR System consists of rounded rectangular and rectangular cages with fenestrations and toothed spikes; used in combination with spacer components. Cages and spacers lock together into geometric configurations to fit patient pathology. Toothed spikes engage superior and inferior vertebral endplates to resist rotation and migration. Device is implanted by a surgeon in a clinical setting to replace damaged vertebral bodies; bone graft material is packed into interior openings. System is intended for use with supplemental internal spinal fixation systems (e.g., pedicle screw systems) to restore biomechanical integrity of the spinal column. Benefits include stabilization of the spine in the presence of tumor or trauma.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Constructed from Polyetheretherketone (PEEK OPTIMA LT) per ASTM F2026. Device features rounded rectangular and rectangular cages with fenestrations and toothed spikes. Modular design allows locking of cages and spacers into various geometric configurations. Mechanical stabilization achieved via endplate engagement. Non-powered, implantable device.

Indications for Use

Indicated for patients requiring replacement of a collapsed, damaged, or unstable vertebral body in the thoracolumbar spine (T1-L5) due to tumor or trauma (e.g., fracture).

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 LLC CPOD/LPOD VBR System (K032064)
• SIGNUS Medical LLC TetrisTM Spinal Implant (K022793)
• Synthes SynexTM Spacer System (K003836)
• Osteotech Inc., VBRTM (K003155)
• DePuy AcroMed, Inc. Stackable CageTM System (K990148)
• Curved PEEK TetrisTM (K041888)

Submission Summary (Full Text)

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K050058/P1/2

MAY 1 7 2005

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

(21 CFR Part 807.92)

## A. Submitter Information

| Submitter's Name:<br>Address:<br>Telephone Number:<br>Fax Number:<br>Contact Person:<br>Date Prepared: | Theken Surgical<br>283 E. Waterloo<br>Akron, Ohio 44319<br>330-773-7677 x221<br>330-773-7697<br>Randy Theken<br>5/16/2005 4:50 PM |
|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <b>B. Device Information</b> | |
| Trade Name: | Theken VU Vertebral Body Replacement (VBR) SYSTEM |
| Common Name: | Vertebral Body Replacement Device |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis (per 21 CFR<br>888.3060) |
| Device Classification: | Class II (per 21 CFR 888.3060)<br>Panel: Orthopedic, Product Code: MQP, Panel Code: 87 |
| Predicate Device: | Theken Surgical LLC CPOD/LPOD VBR System (K032064) |
| Comparative Devices: | SIGNUS Medical LLC TetrisTM Spinal Implant (K022793) |
| | Synthes Spine Company, L.P. |
| | Synthes SynexTM Spacer System (K003836) |
| | Osteotech Inc., VBRTM (K003155) |
| | DePuy AcroMed, Inc. Stackable CageTM System (K990148) |
| Material Composition: | SIGNUS Medical LLC Curved PEEK TetrisTM (K041888)<br>Polyetheretherketone (PEEK OPTIMA LT) per ASTM F2026. |
| Subject Device Description: | The Theken VU VBR SYSTEM is comprised of rounded<br>rectangular and rectangular cages with fenestrations and radii on<br>all sides and toothed spikes which are used in combination with<br>spacer components. The cages and spacer can be locked together<br>into a variety of geometric configurations to fit each individual<br>patient's pathology. The toothed spikes of the rounded rectangular<br>and rectangular cages engage with the superior and inferior end<br>plates of the neighboring vertebral bodies to resist rotation and<br>migration. A single construct is sufficient to be used at all spinal<br>levels and pathologies. |
| Intended Use: | The Theken VU VBR SYSTEM is indicated for use in the<br>thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or<br>unstable vertebral body due to tumor or trauma (e.g., fracture). |
| | The Theken VU VBR SYSTEM is designed to restore the<br>biomechanical integrity of the anterior, middle, and posterior<br>spinal column even in the absences of fusion for a prolonged<br>period. Bone graft material is recommended to be packed into the<br>interior openings of the device prior to implantation. |
| | The Theken VU VBR SYSTEM is intended to be used with<br>supplemental internal spinal fixation systems, such as the Theken<br>BodyForm Thoracolumbar Fixation System(K983622, Approved<br>12/98) or the Theken Coral Pedicle Screw System (K041592,<br>Approved 9/04). |

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## C. Substantial Equivalence

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

- CPOD/LPOD VBR System (K032064), manufactured by Theken Surgical LLC and cleared by the 1) FDA on February 20, 2004.
- 2) Tetris™ Spinal Implant (K022793), manufactured by SIGNUS Medical LLC and cleared by the FDA on April 8, 2003.
- Synthes Synex "M Spacer System (K003836), manufactured by Synthes Spine Company, L.P. and 3) cleared by the FDA on May 29, 2001.
- 4) VBR (K003155), manufactured by Osteotech Inc. and cleared by the FDA on October 16, 2001.
- 4) Stackable Cage™ System (K990148), manufactured by DePuy AcroMed, Inc. and cleared by the FDA on September 3, 1999.
- Curved PEEK Tetris™ (K041888), manufactured by SIGNUS Medical LLC and cleared by the FDA 6) on July 9, 2004.

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 contradictions for use, and have equivalent potential for complications for the risk of use. In addition they all represent a basic design concept in terms of safety and effectiveness, and differ only in minor details. 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 (adherence to GLP), Theken Surgical believes that sufficient evidence exists to reasonably conclude that the VU VBR SYSTEM is substantially equivalent to existing legally marketed devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 7 2005

Mr. Randy Theken Theken Surgical, LLC 283 E Waterloo Road Akron, Ohio 44319

Re: K050058 Trade/Device Name: Theken VU VBR System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: May 9, 2005 Received: May 12, 2005

Dear Mr. Theken:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your became of (2) fe device is substantially equivalent (for the indications felerenced above und have active legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regars the Medical Device Amendments, or to commerce prior to May 20, 1978, are excerdance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). alle Cosmetic Acr (11ct) market the device, subject to the general controls provisions of the Act. The r ou may, therefore, market the act include requirements for annual registration, listing of gencial controls provisions of uactice, 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 If your device is classified (see aborto) als. Existing major regulations affecting your device can may be subject to suen additional controlial control of the 21, Parts 800 to 898. In addition, FDA may be found in the Code of I casial and get and seen and the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dr. 3 issuation of wouldevice complies with other requirements of the Act that FDA has made a delerimiation administered by other Federal agencies. You must of ally it cach all the Act's requirements, including, but not limited to: registration and listing (21 comply with an the Act 3 requirements, and manufacturing practice requirements as set Cr N I art 807), adomig (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Mr. Randy Theken

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin maxing of substantial equivalence of your device to a legally premaired notineation: "The PDF imalings if cation 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 If you desire specific acreed as [phone]. Also, please note the regulation entitled, Comaci the Office of Computine in (21 the Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your response 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,

Stupt Elwards

Miriamm Provost, Ph.D. Acting 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): ____________________________________________________________________________________________________________________________________________________ K050058

Theken VU VBR SYSTEM Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

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

The Theken VU VBR SYSTEM is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absences of fusion for a antonor, maaily and material is recommended to be packed into the interior openings of the device prior to implantation.

The Theken VU VBR SYSTEM is intended to be used 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 × (Part 21 CFR 801 Subpart D) AND/OR

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)

Hypt Churd

(Division Division of General, Restorative. and Neurological Devices

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510(k) Number_________________________________________________________________________________________________________________________________________________________________