RABEA SPINAL IMPLANT

K043316 · Signus Medizintechnik GmbH · MQP · Feb 7, 2005 · Orthopedic

Device Facts

• Record ID: K043316
• Device Name: RABEA SPINAL IMPLANT
• Applicant: Signus Medizintechnik GmbH
• Product Code: MQP · Orthopedic
• Decision Date: Feb 7, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The RABEA™ 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) and is intended for use with supplemental internal fixation. This device is intended to be implanted in pairs. The supplemental internal fixation systems that may be used with the RABEA™ Spinal Implant are the same as those used with the Curved PEEK Tetris™ Spinal Implant and 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

RABEA™ Spinal Implant is a rectangular frame device for vertebral body replacement in thoracolumbar spine (T1-L5). Implanted in pairs; features open upper/lower aspects and wall spikes for anchorage/seating. Forged from radiolucent PEEK (PEEK-OPTIMA™ LT1) with embedded Titanium alloy (TiAl6V4) marker pins for radiographic localization. Available in sizes 5mm-30mm to accommodate patient pathology/anatomy. Used by surgeons in clinical settings; requires supplemental internal fixation (e.g., titanium plate/rod systems). Provides structural support to replace resected/excised vertebral bodies.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and intended use similarities to the predicate device.

Technological Characteristics

Materials: PEEK-OPTIMA™ LT1 (frame) and TiAl6V4 (marker pins). Marker pins comply with ASTM F-136 and ISO 5832/3. Form factor: Rectangular frame with wall spikes. Sizes: 5mm to 30mm. Radiolucent construction with radiopaque markers.

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 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.

Predicate Devices

• Curved PEEK Tetris™ (K041888)

Submission Summary (Full Text)

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510(k) Summary

:

| Submitter: | SIGNUS Medizintechnik GMBH |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Brentanostr. 9 |
| | Alzennau, Germany D-63755 |
| | 49-6023 9166-0 |
| Contact Person: | Tracy L. Gray, RN, BS RAC |
| | Principal Consultant |
| | Alquest, Inc. |
| | Phone: [phone] Fax: [phone] |
| Date Prepared: | November 22, 2004 |
| Trade Name: | RABEATM |
| Classification<br>Name and<br>Number: | 21 CFR 888.3060 |
| Product Code: | MQP |
| Predicate Device | Curved PEEK Tetris™ cleared under K041888 on 8/10/04. |
| Device Description: | The RABEATM Spinal implant is a rectangular frame. The upper and<br>lower aspects of the implant are open and the walls feature spikes which<br>assist in the positive anchorage and seating of the implant between the<br>superior and inferior vertebral bodies. |
| | The frame is forged from PEEK (PEEK-OPTIMATM LT1), which is<br>radiolucent, and incorporates small Titanium alloy (TiAl6V4) marker<br>pins so the device can be located within the body. The marker pins<br>meet ASTM F-136 and ISO 5832/3. |
| | The RABEATM Spinal Implant is available in a variety of sizes ranging<br>from 5mm to 30mm. This enables the surgeon to choose the size suited<br>to the individual pathology and anatomical condition. The RABEATM is<br>implanted in pairs. |
| Intended Use: | The RABEATM Spinal Implant is indicated for use to replace a vertebral<br>body that has been resected or excised due to tumor or trauma/fracture.<br>The device is intended for use as a vertebral body replacement in the<br>thoracolumbar spine (from T1 to L5) and is intended for use with<br>supplemental internal fixation. This device is intended to be implanted<br>in pairs. |
| | The supplemental internal fixation systems that may be used with the<br>RABEATM Spinal Implant are the same as those used with the Curved<br>PEEK Tetris™ Spinal Implant and include, but are not limited to,<br>DePuy AcroMed titanium plate or rod systems (Kaneda SR, University<br>Plate, M2, ISOLA, VSP, Moss, TiMX, and Profile). |
| Statement of<br>Technological<br>Comparison | The subject device and predicate device have the following similarities: |
| | • The same indication for use; |
| | • The same operating principle; |
| | • The same basic design; |
| | • The same materials; |
| | • Implanted using the same surgical techniques and equipment; |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/2 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized symbol consisting of three parallel lines that curve and taper towards the right, with a wavy line beneath them.

FEB - 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Signus Medizintechnik GMBH C/o Ms. Tracy Gray Principal Consultant Alquest, Inc. 4050 Olson Memorial Hwy, Suite 350 Minneapolis, Minnesota 55422

Re: K043316

Trade/Device Name: RABEA™ Spinal Implant Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: November 29, 2004 Received: December 2, 2004

Dear Ms. Gray:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your been and the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreases) 70 ttg ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . conninered prior to that 2011-17-19, in accordance with the provisions of the Federal Food, DNIg, de vices that have been require approval of a premarket approval application (PMA). and Cosmetic Free (110) market the device, subject to the general controls provisions of the Act. The r ou may, merelore, mantes of the Act include requirements for annual registration, listing of general controls provisions of the tice, 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 clusified (600 as a votrols. Existing major regulations affecting your device can may or saterial 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 I lease be advised that I Drimination that your device complies with other requirements of the Act that I Dri has Intatutes and regulations administered by other Federal agencies. You must or any I catal statuated and regisments, including, but not limited to: registration and listing (21 Comply with an the Her 621 CFR Part 801); good manufacturing practice requirements as set CI It I art 6077, naouing (21 CFR Part 820); and if applicable, the electronic forth in the quality Bystems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -- Ms. Tracy Gray

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w yourse of substantial equivalence of your device to a legally prematice notification: "The stassification 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 auropliance 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 other general information on Jour Copsumer 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,

Mark N. Milkenn

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

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

RABEA™ Spinal Implant Device Name:

## Indications for Use:

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The supplemental internal fixation systems that may be used with the RABEA™ Spinal Implant The suppliemental internal triality of the Spinal Implant and include, but are not limited to, are the same as the Curved I ELES Teths - Spania - Spania - Spania - Spania - M2, ISOLA, VSP, Moss, TiMX, and Profile).

Prescription Use ____________ (Per 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)

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

S10(k) Number K043316