VALEO VBR

K073125 · Amedica Corp. · MQP · Dec 5, 2007 · Orthopedic

Device Facts

• Record ID: K073125
• Device Name: VALEO VBR
• Applicant: Amedica Corp.
• Product Code: MQP · Orthopedic
• Decision Date: Dec 5, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Valeo™ VBR is intended for vertebral body replacement to aid in surgical correction and stabilization of the spine. The device is indicated for use in the thoracolumbar spine (T1 to L5) to replace or restore height a collapsed, damaged, diseased, or unstable vertebral body or portion thereof, excised as a result of tumor or trauma (i.e., fracture). It is indicated to achieve decompression of the spinal cord and neural tissues, and to restore the height of a collapsed or damaged vertebral body. The Valeo™ VBR is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. The Valeo™ VBR is always to be used with supplemental internal spinal fixation. Additionally, the Valeo™ VBR may be used with bone graft.

Device Story

Valeo™ VBR acts as a spinal spacer; maintains vertebral body spacing and angulation following partial or total corpectomy. Device implanted during surgery; used in thoracolumbar spine (T1-L5). Functions as structural support to restore biomechanical integrity of spinal column; used in conjunction with supplemental internal spinal fixation and optional bone graft. Benefits patient by restoring height of collapsed/damaged vertebrae and decompressing neural tissues.

Clinical Evidence

Bench testing only.

Technological Characteristics

Manufactured from MC4 ceramic material. Designed for single-level anterior spinal use (T1-L5). Functions as a mechanical spacer for vertebral body replacement.

Indications for Use

Indicated for patients requiring vertebral body replacement in the thoracolumbar spine (T1-L5) due to tumor or trauma-related collapse, disease, or instability. Requires use with supplemental internal spinal 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

• Amedica ARX Spinal System (K051525)

Submission Summary (Full Text)

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K073125

Amedica Valeo™ VBR 510(k)

# 5. 510(k) Summary

| Contact: | Adam Herder<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™ VBR | DEC 05 2007 |
| Manufacturer: | Amedica Corp.<br>615 Arapeen Drive, Suite 302<br>Salt Lake City, UT 84108 | |
| Common Name: | Spinal intervertebral body fixation orthosis | |
| Classification: | 21 CFR §888.3060 | |
| Class: | II | |
| Product Code: | MQP | |

#### Indications For Use:

The Valeo™ VBR is intended for vertebral body replacement to aid in surgical correction and stabilization of the spine. The device is indicated for use in the thoracolumbar spine (T1 to L5) to replace or restore height a collapsed, damaged, diseased, or unstable vertebral body or portion thereof, excised as a result of tumor or trauma (i.e., fracture). It is indicated to achieve decompression of the spinal cord and neural tissues, and to restore the height of a collapsed or damaged vertebral body.

The Valeo™ VBR is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. The Valeo™ VBR is always to be used with supplemental internal spinal fixation. Additionally, the Valeo™ VBR may be used with bone graft.

#### Device Description:

The Valeo™ VBR acts as a spacer to maintain proper vertebral body spacing and angulation following partial or total corpectorny. The Valeo™ VBR is manufactured from MC4, a ceramic material. The Valeo™ VBR is for single level anterior spinal use from T1-L5.

Puer 1. f. 2.

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## Predicate Device(s):

The Valeo™ VBR was shown to be substantially equivalent to the Amedica ARX Spinal System cleared in K051525.

### Performance Standards:

:

:

:

Testing performed indicates the Valeo™ VBR is substantially equivalent to predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure.

Public Health Service

DEC 0 5 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Musculoskeletal Clinical & Regulatory Advisers, LLC % Mr. Adam Herder 1331 H Street NW, 12th Floor Washington, DC 20005

Re: K073125

Trade/Device Name: Valeo™ VBR Regulation Number: 21 CFR 888.3060 Regulation Names: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: November 5, 2007 Received: November 6, 2007

Dear Mr. Herder:

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. Adam Herder

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 the reporting 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 Millman

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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## 4. Indications for Use

510(k) Number (if known): _ Ko 73125

Device Name: Amedica Valeo™ VBR

The Valeo™ VBR is intended for vertebral body replacement to aid in surgical correction and stabilization of the spine. The device is indicated for use in the thoracolumbar spine (T1 to L5) to replace or restore height a collapsed, diseased, or unstable vertebral body or portion thereof, excised as a result of tumor or trauma (i.e., fracture). It is indicated to achieve decompression of the spinal cord and neural tissues, and to restore the height of a collapsed or damaged vertebral body.

The Valeo™ VBR is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. The Valeo™ VBR is always to be used with supplemental internal spinal fixation. Additionally, the Valeo™ VBR may be used with bone graft.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Buchner

Division of General, Restorative. and Neurological Devices

510(k) Number Ko 13125

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