VUSION TS, PS, AND CS PARTIAL VERTEBRAL BODY REPLACEMENTS

K062666 · Ortho Development Corp. · MQP · Jan 25, 2007 · Orthopedic

Device Facts

• Record ID: K062666
• Device Name: VUSION TS, PS, AND CS PARTIAL VERTEBRAL BODY REPLACEMENTS
• Applicant: Ortho Development Corp.
• Product Code: MQP · Orthopedic
• Decision Date: Jan 25, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Vusion™ implants are intended for use in partial spine vertebrectorny procedures for vertebral body replacement. The indications include replacement of a collapsed, damaged, or unstable vertebral body that must be resected or excised due to tumor or trauma. The implants are intended for use with a supplemental rod or plate fixation system.

Device Story

Vusion™ PEEK VBR System consists of implants for partial vertebral body replacement; used in spine surgery to replace collapsed, damaged, or unstable vertebral bodies caused by tumor or trauma. Implants are manufactured from PEEK; designed for use in conjunction with supplemental rod or plate fixation systems to provide stability. Device is intended for use by surgeons in clinical settings. Benefits include structural support for the spinal column following resection or excision of compromised vertebrae.

Clinical Evidence

Bench testing only.

Technological Characteristics

Constructed from PEEK (Polyetheretherketone). Spinal intervertebral body fixation orthosis. Designed for partial vertebral body replacement. Requires supplemental rod or plate fixation.

Indications for Use

Indicated for patients requiring partial vertebral body replacement due to collapsed, damaged, or unstable vertebral bodies resulting from tumor or trauma. Must be used with supplemental rod or plate 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.

Submission Summary (Full Text)

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OrthoDevelopment Corporation c/o Ms. Johanne Young 12187 S. Business Park Drive Draper, UT 84020

JAN 2 5 2007

Re: K062666 Trade Name: Vusion™ PEEK VBR System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: December 11, 2006 Received: December 12, 2006

Dear Ms. Young:

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 - Ms. Johanne Young

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis icter will anow you to orgin mading of substantial equivalence of your device to a legally prematication. The PDF micing sification 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 11 you desire 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 other general 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 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:

K062666 Ortho Development Vusion™ TS, PS, and CS PEEK Partial VBR

## Indications for Use

The Vusion™ implants are intended for use in partial spine vertebrectorny procedures for vertebral body replacement. The indications include replacement of a collapsed, damaged, or unstable vertebral body that must be resected or excised due to tumor or trauma.

The implants are intended for use with a supplemental rod or plate fixation system.

× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of General, Restorative, and Neurological Devices

**510(k) Number** 1066666