ATHLET VERTEBRAL BODY REPLACEMENT SYSTEM

K081332 · Signus Medizintechnik GmbH · MQP · Jun 10, 2008 · Orthopedic

Device Facts

• Record ID: K081332
• Device Name: ATHLET VERTEBRAL BODY REPLACEMENT SYSTEM
• Applicant: Signus Medizintechnik GmbH
• Product Code: MQP · Orthopedic
• Decision Date: Jun 10, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ATHLET™ VBR is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5). The ATHLET™ System is intended for use with supplemental fixation and should be implanted in pairs.

Device Story

ATHLET™ VBR is a lordotic, modular vertebral body replacement system; consists of caudal, cranial, and optional intermediate components of varying heights; assembled to create a construct. Features central cannula for bone graft and lateral fenestrations for bony in-growth. Used in thoracolumbar spine (T1-L5) to replace resected/excised vertebral bodies due to tumor or trauma/fracture. Implanted by surgeons in an OR setting; requires supplemental internal fixation; implanted in pairs. Provides structural support to the spinal column.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Materials: Polyetheretherketone (PEEK-OPTIMA® LT1, ASTM F2026) and titanium alloy marker pins (Ti-6Al-4V, ASTM F136). Modular design with central cannula and lateral fenestrations. Lordotic geometry. Standalone mechanical device; no software or energy source.

Indications for Use

Indicated for patients requiring vertebral body replacement in the thoracolumbar spine (T1-L5) following resection or excision due to tumor or trauma/fracture. Must be used with supplemental internal fixation and implanted in pairs.

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.

Submission Summary (Full Text)

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K0812330

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K081332

## 7. 510(k) Summary

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:

JUN 1 0 2008

| Sponsor: | SIGNUS Medizintechnik GmbII<br>Carl-Zeiss-Strasse 2<br>D-63755 Alzenau, GERMANY<br>Tel. + 49 (0) 6023 9166-136<br>Fax + 49 (0) 6023 9166-161<br>Url: http://www.signus-med.de |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jörg Degen, Regulatory Affairs, QM |
| Proposed Trade Name: | ATHLET™ VBR |
| Device Classification | Class II |
| Classification Name: | Spinal vertebral body replacement device |
| Regulation: | 888.3060 |
| Device Product Code: | MQP |
| Device Description: | The ATHLET™ VBR System is a lordotic, modular vertebral body<br>replacement system. Caudal and cranial components are offered in a variety<br>of heights and are assembled to create a device construct. An intermediate<br>component is also available and is used between one caudal and one cranial<br>component. The device construct comprises a central cannula for bone graft<br>and lateral fenestrations for bony in-growth. |
| Intended Use: | The ATHLET™ VBR is indicated for use to replace a vertebral body that<br>has been resected or excised due to tumor or trauma/fracture. The device is<br>intended for use as a vertebral body replacement in the thoracolumbar spine<br>(from T1 to L5). The ATHLET™ System is intended for use with<br>supplemental fixation and should be implanted in pairs. |
| Materials: | The ATHLET™ VBR components are manufactured from<br>polyetheretherketone (PEEK-OPTIMA® LT1, Invibio™) as described by<br>ASTM F2026. Integral marker pins are manufactured from titanium alloy<br>(Ti-6Al-4V) as described by ASTM F136. |
| Substantial<br>Equivalence: | Documentation was provided which demonstrated the ATHLET™ VBR to<br>be substantially equivalent to previously cleared vertebral body replacement<br>devices. The substantial equivalence is based upon equivalence in basic<br>design, intended use, indications, anatomic sites and performance. |

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Image /page/1/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three thick, curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SIGNUS Medizintechnik GmbH % Karen E. Warden, Ph.D. Representative/Consultant 8202 Sherman Road Chesterland, Ohio 44026

JUN 1 0 2008

Re: K081332

Trade/Device Name: ATHLET™ VBR Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: May 12, 2008 Received: May 12, 2008

Dear Dr. Warden:

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 - Karen E. Warden, Ph.D.

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 Reporting (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 toll-frec number [phone] or [phone] or Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Millerson

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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## Indications for Use Statement

510(k) Number: K081332

Device Name: ATHLETIM VBR

Indications for Use:

The ATHLET™ System is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5). The ATHLET™ system is intended for use with supplemental internal fixation and intended to be implanted in pairs.

Prescription Use X (Per 21 CFR 801.109)

OR

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)

Neil R. Ogden for mkm

Division of General. Re and Neurological Devices

510(k) Number K081332