GRAFT CONTAINMENT DEVICE

K070148 · Nuvasive, Inc. · KWQ · Jul 31, 2007 · Orthopedic

Device Facts

• Record ID: K070148
• Device Name: GRAFT CONTAINMENT DEVICE
• Applicant: Nuvasive, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Jul 31, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Graft Containment Device, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. The device is not intended for load bearing indications.

Device Story

Graft Containment Device consists of surgical mesh made from polyester suture fibers; features reinforced holes for anchoring to bone. Used in spinal fusion procedures to maintain position of weak bony tissue (allografts/autografts). Requires use with traditional rigid fixation; not for load-bearing. Includes optional bone screws made of PEEK, carbon-fiber reinforced PEEK, or titanium. Operated by surgeons in clinical settings.

Clinical Evidence

No clinical data.

Technological Characteristics

Materials: Polyester suture fibers (mesh), PEEK, carbon-fiber reinforced PEEK, or titanium (screws). Form factor: Specialized mesh shapes with reinforced anchoring holes. Non-load bearing.

Indications for Use

Indicated for use in spinal fusion procedures to maintain the relative position of weak bony tissue (allografts or autografts) in conjunction with traditional rigid fixation. Not indicated for load-bearing applications.

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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K070148

#### ડ. 510(K) SUMMARY

JUL 3 1 2007

In accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title of the Code of Federal Regulations Part 807 (21 CFR §807), and in particular §807.92, the following summary of safety and effectiveness information is provided:

## A. Submitted by

Laetitia Cousin Director of Regulatory Affairs and Ouality Assurance NuVasive, Incorporated 4545 Towne Centre Court San Diego, CA 92121 Telephone: [phone] Date Prepared: January 12, 2007.

# B. Device Name

Trade or Proprietary Name: Common or Usual Name: Classification Name:

Graft Containment Device Graft Containment Device Appliance, Fixation, Spinal Intervertebral body, code KWQ.

# C. Predicate Devices

The subject device is substantially equivalent to similar previously cleared devices.

### D. Device Description

The Graft Containment Device consists of a series of specialized shapes of surgical mesh made from commercially available polyester suture fibers. All sizes incorporate regions of reinforced holes to assist secure anchoring of the mesh to tissue. The devices are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

Bone screws intended for anchoring the graft containment device to bone, and made from PEEK, carbon-fiber reinforced PEEK, or titanium are also available.

# E. Intended Use

The Graft Containment Device, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts. The device is not intended for load bearing indications.

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# F. Comparison to Predicate Devices

As was established in this submission, the subject device is substantially equivalent to other devices cleared by the agency for commercial distribution in the United States.

Engineering drawings, labeling, and mechanical testing have demonstrated that the subject device is substantially equivalent, if not identical, to its predicate devices in terms of design, materials of composition, indications for use, and such other characteristics as may be associated with the manufacture of any medical device.

## G. Summary of Non-Clinical Tests

Mechanical testing was presented.

# H. Summary of Clinical Tests

(Not Applicable).

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NuVasive, Incorporated % Ms. Lactitia Cousin Director of Regulatory Affairs and Quality Assurance 4545 Towne Centre Court San Diego, California 92121

JUL 3 1 2007

Re: K070148

> Trade/Device Name: Graft Containment Device Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: June 14, 2007 Received: June 15, 2007

Dear Ms. Cousin:

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. Laetitia Cousin

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 vours.

Barbara Burchard

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

K070148 510(k) Number (if known):

Device Name: Graft Containment Device

Indications for Use:

The Graft Containment Device, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. The device is not intended for load bearing indications.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Berbare Meehup
Division Sign Off

Division of General. Restorative. and Neurological Devices

510(k) Number_KO

Roger Ms.