TETRIS SPINAL IMPLANT

K022793 · Signus Medical, LLC · MQP · Apr 8, 2003 · Orthopedic

Device Facts

• Record ID: K022793
• Device Name: TETRIS SPINAL IMPLANT
• Applicant: Signus Medical, LLC
• Product Code: MQP · Orthopedic
• Decision Date: Apr 8, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TETRIS™ Spinal Implant 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 TETRIS™ Spinal Implant is intended for use with supplemental internal fixation. The supplemental internal fixations systems that may be used with the TETRIS™ Spinal Implant include, but are not limited to, DePuy AcroMed titanium plate or rod systems (Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss, TiMX, and Profile).

Device Story

TETRIS™ Spinal Implant is a hollow, rectangular titanium alloy (Ti6Al4V) frame with lateral fenestrations; features spikes on upper/lower surfaces for anchorage/seating between vertebral bodies. Available in various sizes and wedge-shaped options. Implanted by surgeons in the thoracolumbar spine (T1-L5) to replace resected/excised vertebral bodies due to tumor or trauma/fracture. Used individually or in pairs; requires supplemental internal fixation (e.g., titanium plate or rod systems). Provides structural support to the spinal column post-resection.

Clinical Evidence

Bench testing only. Mechanical testing performed in accordance with FDA's 'Guidance for Industry and FDA staff, Guidance for Spinal System 510(k)s'. Results confirmed safety and effectiveness.

Technological Characteristics

Material: Titanium alloy (Ti6Al4V). Design: Hollow, rectangular frame with lateral fenestrations and anchorage spikes. Form factor: Various sizes and wedge-shaped options. Energy source: None (mechanical implant). Sterilization: Not specified.

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.

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

• Stackable Cage™ System (K001340 and K990148)
• Surgical Titanium Mesh™ System (K003043)

Submission Summary (Full Text)

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APR 0 8 2003

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K022793
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## SECTION 2. SUMMARY AND CERTIFICATION

## A. 510(k) Summary

| Submitter: | SIGNUS Medical LLC<br>6713 Lakeway Drive<br>Chanhassen, MN 55317 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Thomas Hoghaug<br>Signus Medical LLC<br>6713 Lakeway Drive<br>Chanhassen, MN 55317 |
| Date Prepared: | February 4, 2003 |
| Trade Name: | TETRIS™ Spinal Implant |
| Classification Name:<br>and Number: | Vertebral Body Replacement<br>Class II, 21 CFR 888.3060 |
| Product Code: | MQP |
| Predicate Device(s): | The TETRIS™ Spinal Implant is substantially equivalent to<br>the Stackable Cage™ System, manufactured by DePuy<br>AcroMed (K001340 and K990148) and the Surgical<br>Titanium Mesh™ System, manufactured by DePuy<br>AcroMed (K003043). |
| Device Description: | The TETRIS™ Spinal Implant is a hollow, rectangular<br>frame with lateral fenestrations. The upper and lower<br>aspects of the implants are open and the walls feature<br>spikes, which assist in the positive anchorage and seating of<br>the implants between the superior and inferior vertebral<br>bodies. The frame is forged from a titanium alloy<br>(Ti6Al4V). |
| The TETRIS™ Spinal Implant is available in a variety of<br>sizes and a wedge shaped option. This enables the surgeon<br>to choose the size suited to the individual pathology and<br>anatomical condition. The TETRIS™ may be used<br>individually or paired based on anatomy and amount of<br>bone resected by the surgeon. When using two implants,<br>care should be taken not to mix flat and wedged shaped<br>devices. | |
| Intended Use: | The TETRIS™ Spinal Implant is indicated for use to<br>replace a vertebral body that has been resected or excised<br>due to tumor or trauma/fracture. The device is intended for<br>use as a vertebral body replacement in the thoracolumbar<br>spine (from T1 to L5).<br><br>The TETRIS™ Spinal Implant is intended for use with<br>supplemental internal fixation. The supplemental internal<br>fixations systems that may be used with the TETRIS™<br>Spinal Implant include, but are not limited to, DePuy<br>AcroMed titanium plate or rod systems (Kaneda SR,<br>University Plate, M-2, ISOLA, VSP, Moss, TiMX, and<br>Profile). |
| Functional and<br>Safety Testing | Functional and safety testing of the TETRIS™ Spinal<br>Implant consisted of mechanical testing in accordance with<br>the "Guidance for Industry and FDA staff, Guidance for<br>Spinal System 510(k)s. The results of the examination and<br>testing were successful and did not raise any issues of<br>safety and effectiveness of the device. |
| Conclusion: | The TETRIS™ Spinal Implant is substantially equivalent to<br>the Stackable Cage™ System (K001340 and K990148),<br>manufactured by DePuy AcroMed and the Surgical<br>Titanium Mesh™ System, manufactured by DePuy<br>AcroMed (K003043) based on the device's similarities in<br>materials, functional design and indications for use. |

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K022793
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 0 8 2003

Mr. Thomas Hoghaug SIGNUS Medical LLC 6713 Lakeway Drive Chanhassen, MN 55317

K022793 Re:

Trade Name: TETRIS™ Spinal Implant Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: February 4 and 7, 2003 Received: February 7 and 10, 2003

Dear Mr. Hoghaug:

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. Thomas Hoghaug

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 (301) 594- . 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/dsma/dsmamain.html

Sincerely yours,

Mark N Miller

Celia M. Witten, Ph.D., M.D. 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 Page

Device Name: TETRIS™ Spinal Implant

Indications for Use: The TETRIS™ Spinal Implant 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 TETRIS™ Spinal Implant is intended for use with supplemental internal fixation. The supplemental internal fixations systems that may be used with the TETRIS™ Spinal Implant include, but are not limited to, DePuy AcroMed titanium plate or rod systems (Kaneda SR, University Plate, M2, ISOLA, VSP, Moss, TiMX, and Profile).

Concurrence of CDRH, Office of Device Evaluation (ODE)

for Mark N. McKenna

Division Sign-Off) Division of General, Restorative and Neurological Devices

022793 510(k) Number _