VISTA -S DEVICE

K070382 · Zimmer Trabecular Metal Technology · MQP · May 30, 2007 · Orthopedic

Device Facts

• Record ID: K070382
• Device Name: VISTA -S DEVICE
• Applicant: Zimmer Trabecular Metal Technology
• Product Code: MQP · Orthopedic
• Decision Date: May 30, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Vista -S Device is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) for partial replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Vista -S Device is intended for use with supplemental internal spinal fixation systems. The Vista -S Device may be used with bone graft.

Device Story

Vista-S Device is a box-shaped vertebral body replacement implant; fabricated from polyetheretherketone (PEEK). Designed for partial replacement of collapsed, damaged, or unstable vertebral bodies in the thoracic and lumbar spine (T1-L5). Features superior and inferior surface teeth for initial stability; includes press-fit radiopaque markers for postoperative imaging. Intended for use in conjunction with supplemental internal spinal fixation systems and optional bone graft. Implanted by surgeons during spinal procedures to restore structural integrity following tumor or trauma. Benefits include stabilization of the spinal column.

Clinical Evidence

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

Technological Characteristics

Material: Polyetheretherketone (PEEK). Form factor: Box-shaped vertebral body replacement with surface teeth for stability. Includes radiopaque markers. Intended for use with supplemental internal spinal fixation. No software or electronic components.

Indications for Use

Indicated for patients requiring partial vertebral body replacement in the thoracolumbar spine (T1-L5) due to tumor or trauma (fracture). Must be used with supplemental internal spinal fixation; may be used with bone graft.

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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K070382

# 510(k) Summary

MAY 3 0 2007

| Submitter: | Zimmer Trabecular Metal Technology, Inc.<br>10 Pomeroy Road<br>Parsippany, New Jersey 07054 |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jennifer P. Harakal<br>Senior Specialist, Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | April 25, 2007 |
| Trade Name: | Vista®-S Device |
| Common Name: | Vertebral Body Replacement Device |
| Classification Name and<br>Reference: | Spinal Intervertebral Body Fixation Orthosis<br>21 CFR § 888.3060, MQP |

#### DEVICE DESCRIPTION

The Vista -S Device is a box-shaped vertebral body replacement fabricated from polyetheretherketone (PEEK) that is designed to accommodate the partial replacement of a vertebral body in the thoracic and lumbar region of the spine. The device is available in a variety of cross sections and heights to accommodate variations in the individual pathology and anatomic condition of the patient. The superior and inferior surfaces of the device contain a pattern of teeth to provide for initial stability. Radiopaque markers are press fit into the device to aid in determining the location of the implant postoperatively.

### INDICATIONS FOR USE

The Vista -S Device is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) for partial replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Vista -S Device is intended for use with supplemental internal spinal fixation systems. The Vista -S Device may be used with bone graft.

## SUBSTANTIAL EQUIVALENCE

Documentation was provided which demonstrated that the Vista -S Device is substantially equivalent to its predicate devices with respect to intended use/indications for use, materials, technological characteristics and basic principles of operation.

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Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Zimmer Trabecular Metal Technology, Inc. % Ms. Jennifer P. Harakal Senior Specialist, Regulatory Affairs 10 Pomeroy Road Parsippany, New Jersey 07054

MAY 3 0 2007

Re: K070382

Trade Name: Vista®-S Device Regulation Number: 21 CFR 888.3060 Regulation Names: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Codes: MOP Dated: February 6, 2007 Received: February 8, 2007

Dear Ms. Harakal:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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 (PMA) application. You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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. This letter will allow you to begin marketing your device as described in your 510(k) premarket

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notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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

for

Mark N. Mcl 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: Vista®-S Device

Indications for Use:

The Vista -S Device is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) for partial replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Vista -S Device is intended for use with supplemental internal spinal fixation systems. The Vista -S Device may be used with bone graft.

Prescription Use_ X (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)

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R

Division Sign-Off (Division Signeral, Restorative, Division of Neurological Devices

510(k) Number L090382