VALEO SPACER SYSTEM

K091278 · Amedica Corp. · MAX · Jan 28, 2010 · Orthopedic

Device Facts

• Record ID: K091278
• Device Name: VALEO SPACER SYSTEM
• Applicant: Amedica Corp.
• Product Code: MAX · Orthopedic
• Decision Date: Jan 28, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Valeo Spacer System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. The device must be used with additional anterior or posterior instrumentation to augment stability. The Valeo Spacer System -C is intended for use at one level in the cervical spine, from C3 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The Valeo Spacer System -C is to be used in patients who have had six weeks of non-operative treatment. The Valeo Spacer System -AL. -TL. -PL. -XT are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Valeo Spacer System -AL, -TL, -PL, -XT is to be used in patients who have had six months of nonoperative treatment.

Device Story

Valeo Spacer System comprises cervical and lumbar interbody fusion devices and associated surgical instrumentation; manufactured from MC2 ceramic material. Devices implanted by surgeons during spinal fusion procedures to restore disc height and facilitate fusion; requires supplemental anterior or posterior fixation. Provides structural support for vertebral bodies; used in conjunction with autograft. Sterile delivery. Clinical benefit includes stabilization of spinal segments in patients with degenerative disc disease.

Clinical Evidence

Bench testing only; compliance with ASTM F2077 performance standards demonstrated.

Technological Characteristics

Intervertebral body fusion device; material: MC2 ceramic; provided sterile. Adheres to ASTM F2077 performance standards.

Indications for Use

Indicated for skeletally mature patients requiring intervertebral body fusion. Cervical (-C): one level C3-T1 for discogenic neck pain after 6 weeks of failed non-operative treatment. Lumbar (-AL, -TL, -PL, -XT): one or two contiguous levels L2-S1 for degenerative disc disease with up to Grade 1 spondylolisthesis after 6 months of failed non-operative treatment. Must be used with autograft and supplemental fixation.

Regulatory Classification

Identification

An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.

Special Controls

*Classification.* (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Submission Summary (Full Text)

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## 510(k) Summary

| Contact: | Robert M. Wolfarth, CQA<br>Amedica Corporation<br>801-839-3500 | |
|--------------------|-------------------------------------------------------------------------|--------------|
| Device Trade Name: | Valeo® Spacer System | JAN 2 8 2010 |
| Manufacturer: | Amedica Corporation<br>1885 West 2100 South<br>Salt Lake City, UT 84119 | |
| Common Name: | Intervertebral body fusion device | |
| Classification: | 29 CFR §888.3080 | |
| Class: | II | |
| Product Code: | MAX, ODP | |

#### Indications For Use:

The Valeo Spacer System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. The device must be used with additional anterior or posterior instrumentation to augment stability.

The Valeo Spacer System -C is intended for use at one level in the cervical spine, from C3 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The Valeo Spacer System -C is to be used in patients who have had six weeks of non-operative treatment.

The Valeo Spacer System -AL. -TL. -PL. -XT are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Valeo Spacer System -AL, -TL, -PL, -XT is to be used in patients who have had six months of nonoperative treatment.

#### Device Description:

The Valeo Spacer System consists of cervical and lumbar component spinal interbody fusion devices as well as instrumentation designed specifically for the implantation of these devices. The Valeo Spacer System is manufactured from MC2, a ceramic material, and is provided sterile.

### Predicate Device(s):

The Valeo Spacer System was shown to be substantially equivalent to previously cleared devices and has the same indications for use, design, function, and materials used.

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#### Performance Standards:

Testing performed on this device indicates that the Valeo Spacer System is substantially equivalent to predicate devices. ASTM F2077 performance standards were adhered to and all applicable requirements were met.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

JAN 2 8 2010

Amedica Corporation % Mr. Robert M. Wolfarth, CQA Director, Regulatory Affairs and Quality Assurance 1885 West 2100 South Salt Lake City, Utah 84119

Re: K091278

Trade/Device Name: Valeo® Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, ODP Dated: January 21, 2010 Received: January 25, 2010

Dear Mr. Wolfarth:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Mr. Robert M. Wolfarth, COA

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm111800 htm fars the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Barbeze Prichup
Mark N. Mallek

Mark N. Melkers Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

#### 510(k) Number (if known): K091278

### Device Name: Valeo® Spacer System

The Valeo® Spacer System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. The device must be used with additional anterior or posterior instrumentation to augment stability.

The Valeo® Spacer System -C is intended for use at one level in the cervical spine, from C3 to Tl, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The Valeo Spacer System -C is to be used in patients who have had six weeks of non-operative treatment.

The Valeo® Spacer System -AL, -TL, -PL, -XT are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Valeo Spacer System -AL, -TL, -PL, -XT is to be used in patients who have had six months of nonoperative treatment.

Prescription Use V (Part 29 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (29 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)

Al

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

K091278 510(k) Number_