MOBIS SPINAL IMPLANT

K061082 · Signus Medizintechnik GmbH · MQP · Dec 18, 2006 · Orthopedic

Device Facts

• Record ID: K061082
• Device Name: MOBIS SPINAL IMPLANT
• Applicant: Signus Medizintechnik GmbH
• Product Code: MQP · Orthopedic
• Decision Date: Dec 18, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MOBIS® 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. The MOBIS® may be implanted singularly or in pairs. The supplemental internal fixation systems that may be used with the MOBIS® includes, but is not limited to, DePuy AcroMed titanium plate or rod systems (Kaneda SR, University Plate, M2, ISOLA, VSP, Moss, TiMX, and Profile.)

Device Story

MOBIS® Spinal Implant is a vertebral body replacement device for the thoracolumbar spine. It functions as a structural spacer to replace resected or excised vertebral bodies due to tumor or trauma. The device is implanted by a surgeon during spinal procedures, typically in conjunction with supplemental internal fixation systems (e.g., titanium plates or rods). The device is identical to the predicate TETRIS™ system, with the addition of titanium or tantalum marker pins for radiographic visualization. It provides mechanical support to the spinal column, aiding in stabilization and patient recovery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Spinal intervertebral body fixation orthosis. Materials: PEEK with titanium or tantalum marker pins. Form factor: vertebral body replacement implant. Sterilization: standard methods consistent with predicate. No software or electronic components.

Indications for Use

Indicated for vertebral body replacement in thoracolumbar spine (T1-L5) following resection or excision due to tumor or trauma/fracture. 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

• Curved PEEK TETRIS™ (K041888)

Submission Summary (Full Text)

{0}------------------------------------------------

## DEC 1 8 2006

## 510(k) Summary

| Submitter: | SIGNUS Medizintechnik GMBH<br>Carl-Zeiss-Str. 2<br>Alzennau, Germany D-63755 |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tracy L. Gray, RN, BS RAC<br>Principal Consultant<br>Alquest, Inc.<br>Phone: [phone] Fax: [phone] |
| Date Prepared: | 12/12/06 |
| Trade Name: | MOBIS® |
| Classification Name and Number: | 21 CFR 888.3060 |
| Product Code: | MQP |
| Predicate Device | Curved PEEK TETRIS™ cleared under K041888 on 8/10/24. |
| Device Description: | The MOBIS® Spinal implant is the same as the predicate device except<br>that it is supplied with either Titanium or Tantalum marker pins. |
| Intended Use: | The MOBIS® Spinal Implant has the same indication for use as the<br>predicate device. |
| Statement of Technological Comparison | The subject device have the following similarities:<br>The same indication for use; The same operating principle; The same basic design; The same materials; Implanted using the same surgical techniques and equipment; Used in conjunction with the same types of supplemental internal fixation systems; The same manufacturing environment; The same sterilization process; and The same packaging configurations. In summary, the MOBIS®, as described in this submission is, in the opinion of SIGNUS GmbH, substantially equivalent to the predicate device. |
| Conclusion: | The MOBIS® as modified in this submission is substantially equivalent to the predicate device, the Curved PEEK TETRIS™, cleared under K041888. This conclusion is based upon the similarities of the devices in terms of functional design, indication for use, principles of operation. |

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SIGNUS Medizintechnik GMBH c/o Ms. Tracy Gray Alquest Medical 6713 Lakeway Drive Chanhassen, Minnesota 55317

DEC I 8 2006

Re: K061082

Trade Name: MOBIS® Spinal Implant Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: November 17, 2006 Received: November 21, 2006

Dear Ms. Grey:

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.

{2}------------------------------------------------

## Page 2 -- Ms. Tracy Gray

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/industry/support/index.html.

Sincerely yours,

Barbara Buend

Mark N. Melkerson, M.S. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

## Indications for Use

510(k) Number:

K061082

Device Name:

MOBIS® Spinal Implant

Indications For Use:

The MOBIS® 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.

The MOBIS® may be implanted singularly or in pairs.

The supplemental internal fixation systems that may be used with the MOBIS® includes, but is not limited to, DePuy AcroMed titanium plate or rod systems (Kaneda SR, University Plate, M2, ISOLA, VSP, Moss, TiMX, and Profile.)

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)

Varbare Bneup

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

Page 1 of 1

**510(k) Number** *K061082*