TOSCA II ANTERIOR CERVICAL PLATE SYSTEM

K080815 · Signus Medizintechnik GmbH · KWQ · Apr 23, 2008 · Orthopedic

Device Facts

• Record ID: K080815
• Device Name: TOSCA II ANTERIOR CERVICAL PLATE SYSTEM
• Applicant: Signus Medizintechnik GmbH
• Product Code: KWQ · Orthopedic
• Decision Date: Apr 23, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TOSCA II Anterior Cervical Plate System is intended for anterior cervical fixation for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudarthrosis and failed previous fusion. WARNING: The TOSCA II Anterior Cervical Plate System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Device Story

TOSCA II Anterior Cervical Plate System consists of titanium alloy plates and screws of varying sizes/lengths; includes variable angle screws and center graft screw. Used by surgeons in clinical settings for anterior cervical spine fixation. Device provides mechanical stabilization to facilitate fusion in patients with degenerative, traumatic, or neoplastic spinal conditions. Surgeon selects appropriate components to secure the construct to the anterior cervical spine. Output is a rigid internal fixation construct. Benefits include spinal stabilization and support for bone healing.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and performance characteristics.

Technological Characteristics

Components manufactured from titanium alloy (Ti-6Al-4V per ASTM F136). System includes plates, variable angle screws, and center graft screws. Mechanical fixation device; no energy source or software.

Indications for Use

Indicated for anterior cervical fixation in patients with degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, spinal deformities (scoliosis, kyphosis, lordosis), tumor, pseudarthrosis, or failed previous fusion. Contraindicated for posterior element (pedicle) fixation in cervical, thoracic, or lumbar spine.

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

• TOSCA Anterior Cervical Plate System

Submission Summary (Full Text)

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## K080815

## 7. 510(k) Summary

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APR 2 3 2008

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| Sponsor: | SIGNUS Medizintechnik GmbH<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 |
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| Contact Person: | Elisabeth Wroblewski, Regulatory Affairs, QMR |
| Proposed Trade Name: | TOSCA II Anterior Cervical Plate System |
| Regulation | 888.3060 - Spinal Intervertebral Body Fixation Orthosis |
| Device Class | Class II |
| Device Product Code: | KWQ |
| Device Description: | The TOSCA II Anterior Cervical Plate System comprises plate and screw<br>components in a variety of sizes and lengths. Variable angle screws and a<br>Center graft screw are offered. |
| Intended Use: | The TOSCA II Anterior Cervical Plate System is intended for anterior<br>cervical fixation for the following indications: degenerative disc disease (as<br>defined by neck pain of discogenic origin with degeneration of the disc<br>confirmed by patient history and radiographic studies), spondylolisthesis,<br>trauma (i.e., fracture or dislocation), spinal stenosis, deformities or<br>curvatures (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudarthrosis<br>and failed previous fusion.<br>WARNING: The TOSCA II Anterior Cervical Plate System is not intended<br>for screw attachment or fixation to the posterior elements (pedicles) of the<br>cervical, thoracic or lumbar spine. |
| Materials: | The TOSCA II Anterior Cervical Plate System components are<br>manufactured from titanium alloy (Ti-6Al-4V per ASTM F136). |
| Substantial<br>Equivalence: | Documentation was provided which demonstrated the TOSCA II Anterior<br>Cervical Plate System to be substantially equivalent to the previously<br>cleared TOSCA Anterior Cervical Plate System. The substantial<br>equivalence is based upon equivalence in basic design, intended use,<br>indications, anatomic sites and performance. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle faces to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

APR 2 3 2008

Re: K080815 Trade/Device Name: TOSCA II Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: March 20, 2008 Received: March 24, 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 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-free number [phone]or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Millikan

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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## 6. Indications for Use Statement

510(k) Number:

Device Name: TOSCA II Anterior Cervical Plate System

Indications for Use:

The TOSCA II Anterior Cervical Plate System is intended for anterior cervical fixation for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures, (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudarthrosis and failed previous fusion.

WARNING: The TOSCA II Anterior Cervical Plate System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

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)

eilke Ogl

(Division Sig (Division of General, Restorative, and Neurological Devices

510(k) Number K080815

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