VALEO CERVICAL PLATE SYSTEM

K071990 · Amedica Corp. · KWQ · Oct 29, 2007 · Orthopedic

Device Facts

• Record ID: K071990
• Device Name: VALEO CERVICAL PLATE SYSTEM
• Applicant: Amedica Corp.
• Product Code: KWQ · Orthopedic
• Decision Date: Oct 29, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Valeo™ Cervical Plate System is intended for anterior screw fixation at the vertebral bodies of the cervical spine (C2-C7). The Valeo™ Cervical Plate System is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain in discogenic origin of the disc confirmed by patient history and radiographic studies), spinal stenosis, spondylolisthesis, deformity (defined as kyphosis, and scoliosis), trauma (including fractures), tumors, pseudoarthrosis, and/or failed previous fusions. This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. The device is intended for anterior cervical intervertebral body fusions only.

Device Story

Valeo™ Cervical Plate System consists of titanium alloy plates and screws; provides temporary anterior stabilization of cervical spine (C2-C7) during intervertebral fusion. Used by surgeons in clinical/OR settings. Device acts as mechanical fixation to maintain alignment while bone fusion develops. Benefits include spinal stability for patients with degenerative disc disease, trauma, or deformity. No software or electronic components.

Clinical Evidence

Bench testing only. Adherence to ASTM F1717 performance standards confirmed.

Technological Characteristics

Constructed from wrought Ti-6Al-4V titanium alloy per ISO 5832-3. Mechanical spinal fixation system consisting of plates and screws. No software, electronics, or energy sources.

Indications for Use

Indicated for patients requiring temporary anterior cervical spine stabilization (C2-C7) during fusion. Conditions include degenerative disc disease, spinal stenosis, spondylolisthesis, deformity (kyphosis/scoliosis), trauma, tumors, pseudoarthrosis, and failed previous fusions. Contraindicated for posterior element (pedicle) screw attachment.

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

• DePuy DOC (K982443)
• Medtronic Atlantis (K021461)
• Medtronic Orion (K973854)
• Synthes Anterior CSLP System (K000536)
• Theken Tether ACFS (K010466)
• EBI/Biomet Vuelock (K010003)
• NuVasive SmartPlate Gradient Plus (K053581)
• EBI SpineLink (K992920)
• Aesculap ABC Extension Plate (K040017)

Submission Summary (Full Text)

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# 107199

307 2 9 2007

## 510(k) Summary

| Contact: | Glenn Stiegman<br>Musculoskeletal Clinical & Regulatory Advisers, LLC<br>1331 H Street NW, 12th Floor<br>Washington, DC 20005<br>202.552.5800 |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name: | Valeo™ Cervical Plate System |
| Manufacturer: | Amedica Corp.<br>615 Arapeen Drive, Suite 302<br>Salt Lake City, UT 84108 |
| Common Name: | Spinal Fixation Device |
| Classification: | 21 CFR §888.3060 |
| Class: | II |
| Product Code: | KWO |

#### Indications For Use:

The Valeo™ Cervical Plate System is intended for anterior screw fixation at the vertebral bodies of the cervical spine (C2-C7). The Valeo™ Cervical Plate System is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain in discogenic origin of the disc confirmed by patient history and radiographic studies), spinal stenosis, spondylolisthesis, deformity (defined as kyphosis, and scoliosis), trauma (including fractures), tumors, pseudoarthrosis, and/or failed previous fusions.

This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. The device is intended for anterior cervical intervertebral body fusions only.

#### Device Description:

The Valeo™ Cervical Plate System is comprised of an assortment of titanium alloy plates and screws that act to stabilize the spine during the intervertebral fusion process. The Valeo™ Cervical Plate System is manufactured from wrought Ti-6A1-4V in accordance with ISO 5832-3.

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#### Predicate Device(s):

The Valeo™ Cervical Plate System was shown to be substantially equivalent to previously cleared devices and has the same indications for use, design, function, and materials used. The cited references include:

- DePuy DOC (K982443) .
- Medtronic Atlantis (K021461) .
- Medtronic Orion (K973854) .
- Synthes Anterior CSLP System (K000536) .
- Theken Tether ACFS (K010466) .
- EBI/Biomet Vuelock (K010003) .
- NuVasive SmartPlate Gradient Plus (K053581) .
- EBI SpineLink (K992920) .
- Aesculap ABC Extension Plate (K040017) .

#### Performance Standards:

Testing performed on this device indicates that the Valeo™ Cervical Plate System is substantially equivalent to predicate devices. ASTM F1717 performance standards were adhered to and all applicable requirements were met.

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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 consists of a stylized eagle with three stripes representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 9 2007

Amedica Corporation % Musculoskeletal Clinical Regulatory Advisers, LLC Mr. Glenn Stiegman 1331 H Street Northwest, 12th Floor Washington, District of Columbia 20005

Re: K071990

Trade/Device Name: Valeo™ Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: October 12, 2007 Received: October 15, 2007

Dear Mr. Stiegman:

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 (OS) 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. Glenn Stiegman

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 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Mark M. Mulkeran

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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### Indications for Use

510(k) Number (if known):

Device Name: Valeo™ Cervical Plate System

The Valeo™ Cervical Plate System is intended for anterior screw fixation at the vertebral bodies of the cervical spine (C2-C7). The Valeo™ Cervical Plate System is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain in discogenic origin of the disc confirmed by patient history and radiographic studies), spinal stenosis, spondylolisthesis, deformity (defined as kyphosis, and scoliosis), trauma (including fractures), tumors, pseudoarthrosis, and/or failed previous fusions.

This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. The device is intended for anterior cervical intervertebral body fusions only.

V Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR -

Over-The-Counter Use (21 CFR 801 Subpart C)

KO71990

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark M. Milheim

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

**510(k) Number**