PEEK TETRIS SPINAL IMPLANT

K031757 · Signus Medical, LLC · MQP · Jul 30, 2003 · Orthopedic

Device Facts

• Record ID: K031757
• Device Name: PEEK TETRIS SPINAL IMPLANT
• Applicant: Signus Medical, LLC
• Product Code: MQP · Orthopedic
• Decision Date: Jul 30, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PEEK 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 PEEK TETRIST™ Spinal Implant is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the PEEK 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).

Device Story

PEEK Tetris™ is a hollow, rectangular spinal implant frame with lateral fenestrations and wall spikes for anchorage between vertebral bodies. Device is forged from PEEK (polyetheretherketone) for radiolucency, incorporating titanium alloy marker pins for radiographic localization. Available in various sizes and wedge-shaped options to accommodate individual patient pathology and anatomy. Used by surgeons in spinal procedures to replace resected or excised vertebral bodies. Requires supplemental internal fixation (e.g., titanium plate or rod systems) to stabilize the construct. Benefits include structural support for the spinal column following tumor or trauma-related resection.

Clinical Evidence

Bench testing only. No clinical data presented.

Technological Characteristics

Material: PEEK (polyetheretherketone) with titanium alloy marker pins. Form factor: Hollow, rectangular frame with lateral fenestrations and spikes. Connectivity: None. Energy source: None. Sterilization: Not specified.

Indications for Use

Indicated for 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

• Titanium Tetris™ (K022793)

Reference Devices

• DePuy AcroMed titanium plate or rod systems (Kaneda SR, University Plate, M2, ISOLA, VSP, Moss, TiMX, and Profile)

Submission Summary (Full Text)

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K031757
Pi of 2
PEEK Tetris™

SIGNUS Medical LLC Special 510(k)

JUL 3 0 2003

## Appendix F

### 510(k) Summary

| Submitter: | SIGNUS Medical LLC |
|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 6713 Lakeway Drive |
| | Chanhassen, MN 55317 |
| | |
| Contact Person: | Mr. Thomas Hoghaug |
| | Managing Director |
| | Phone: [phone] |
| | Fax: [phone] |
| Date Prepared: | June 3, 2003 |
| Trade Name: | PEEK Tetris™ |
| Classification Name<br>and Number: | 21 CFR 888.3060 |
| Product Code: | MQP |
| Predicate Device<br>Name and 510(k)<br>Number | Titanium Tetris™<br>K022793 |
| Device Description: | DEVICE DESCRIPTION<br>The PEEK Tetris™ Spinal Implant is a hollow, rectangular<br>frame with lateral fenestrations. The upper and lower aspects of<br>the implants are open and the walls feature spikes, which assist<br>in the positive anchorage and seating of the implants between<br>the superior and inferior vertebral bodies. The frame is forged<br>from PEEK which is radiolucent and incorporates Titanium<br>alloy marker pins so the device can be located within the body.<br>The PEEK Tetris™ Spinal Implant is available in a variety of<br>sizes and a wedge shaped option. This enables the surgeon to<br>choose the size suited to the individual pathology and<br>anatomical condition. |
| Intended Use: | The PEEK Tetris™ Spinal Implant is indicated for use to<br>replace a vertebral body that has been resected or excised due to<br>tumor or trauma/fracture. The device is intended for use as a<br>vertebral body replacement in the thoracolumbar spine (from T1<br>to L5). |
| | The PEEK TETRIST™ Spinal Implant is intended for use with<br>supplemental internal fixation. |
| | The supplemental internal fixation systems that may be used<br>with the PEEK Tetris™ Spinal Implant include, but are not<br>limited to, DePuy AcroMed titanium plate or rod systems<br>(Kaneda SR, University Plate, M2, ISOLA, VSP, Moss, TiMX,<br>and Profile). |
| Statement of<br>Technological<br>Comparison | Representative samples of the device underwent testing to<br>demonstrate comparable functional and performance<br>characteristics to the predicate device. |
| | The patient contact materials of the PEEK Tetris™ are<br>processed in the same manner and are identical to those used in<br>other legally marketed predicate devices from SIGNUS that<br>have undergone appropriate biocompatibility testing. Therefore<br>biocompatibility testing of the PEEK Tetris™ has been fulfilled<br>by analogy to those devices. |
| Conclusion: | The PEEK Tetris™ is substantially equivalent to the Titanium<br>Tetris™. This conclusion is based upon the fact that this device<br>is substantially equivalent to the predicate device in terms of<br>functional design, indications for use, principles of operation<br>and test performance characteristics. |

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PEEK Tetris™

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized representation of three human figures, possibly representing individuals or families, under a protective wing-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 0 2003

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

Re: K031757

Trade Name: PEEK Tetris™ Spinal Implant Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: July 7, 2003 Received: July 8, 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 [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/dsma/dsmamain.html

Sincerely yours.

Sincerely yours,

Mark A. Mellar

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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Image /page/4/Picture/0 description: The image shows a sequence of characters and a trademarked name. The characters "K O 3 1 7" are followed by a stylized "5" and a "7". Below the characters, the text "PEEK Tetris™" is visible, indicating a product or brand name.

SIGNUS Medical LLC Special 510(k)

# Appendix B

#### Indications for Use Statement

TBD 510(k) Number (if known)

Device Name PEEK Tetris™

The PEEK Tetris™ Spinal Implant is indicated for use to replace a Indications vertebral body that has been resected or excised due to tumor or for Use trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5).

> The PEEK Tetris™ Spinal Implant is intended for use with supplemental internal fixation.

The supplemental internal fixation systems that may be used with the PEEK 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).

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

#### Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801. 109)

OR Over-The-Counter Use

[signature]

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

510(k) Number

Appendix B Page 1

06/03/03

CONFIDENTIAL