NUVASIVE MASH

K023319 · Nuvasive, Inc. · MQP · Mar 4, 2003 · Orthopedic

Device Facts

• Record ID: K023319
• Device Name: NUVASIVE MASH
• Applicant: Nuvasive, Inc.
• Product Code: MQP · Orthopedic
• Decision Date: Mar 4, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NuVasive® Mesh is a vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neural tissues. The NuVasive® Mesh is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft material may be used at the surgeon's discretion.

Device Story

NuVasive Mesh is an implantable titanium vertebral body replacement device; used in thoracic and lumbar spine (T1-L5). Device features hollow core for bone graft packing and rhombic pattern wall holes; ends include small spikes/teeth to grip adjacent vertebral endplates and resist expulsion. Available in various shapes/sizes to match patient anatomy. Implanted by surgeons during spinal procedures to replace resected/excised vertebral bodies, restore height, and decompress neural tissues. Requires use with supplemental internal spinal fixation systems. Benefits include structural support for collapsed vertebrae and facilitation of spinal fusion.

Clinical Evidence

No clinical data.

Technological Characteristics

Titanium implant; hollow core for bone graft; rhombic pattern wall holes; endplate spikes/teeth for fixation; available in multiple sizes/shapes; mechanical testing performed.

Indications for Use

Indicated for patients with diseased or damaged vertebral bodies in the thoracolumbar spine (T1-L5) due to tumor or fracture requiring height restoration and decompression of spinal cord/neural tissues. Must be used 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.

Submission Summary (Full Text)

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K023319

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## VII. 510(k) Summary

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:

MAR 0 4 2003

# A. Submitted by

Laetitia Bernard Manager of Regulatory Affairs and Quality Assurance NuVasive®, Incorporated 10065 Old Grove Road San Diego, CA 92131 Telephone: [phone] Date Prepared: October 3, 2002.

### B. Device Name

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

NuVasive® Mesh Vertebral Body Replacement Device Vertebral Body Replacement Device

### C. Predicate Devices

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

### D. Device Description

The NuVasive® Mesh is an implantable titanium vertebral body replacement device indicated for use in the thoracic and lumbar spine (i.e., T1 to L.5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.

A plurality of rhombic pattern holes are built in the wall, transverse to the longitudinal axis. The hollow core allows for packing of bone grafting materials to help promote a solid fusion. A ring of small spikes or teeth on each end of the device serves to grip the endplates of the adjacent vertebrae to resist expulsion.

The device is available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

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## E. Intended Use

KO23319 Puge 2 of 2

The NuVasive® Mesh is a vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neural tissues. The NuVasive® Mesh is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft material may be used at the surgeon's discretion.

### 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 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 a stylized symbol resembling three human profiles or faces arranged in a row, with flowing lines beneath them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 0 4 2003

Ms. Laetitia Bernard Manager of Regulatory Affairs and Quality Assurance NuVasive. Inc. 10065 Old Grove Road, Suite A San Diego, CA 92131

Re: K023319

Trade/Device Name: NuVasive Mesh Regulation Number: 21 CFR 888.3060 Regulation Name: Vertebral body replacement device Regulatory Class: II Product Code: MQP Dated: January 3, 2003 Received: January 6, 2003

Dear Ms. Bernard:

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 Bernard

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N Milkman

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### V. Draft Labeling

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#### A. Indications for Use

510(k) Number (if known): KO23319

Device Name: NuVasive® Mesh

Indications for Use:

The NuVasive® Mesh is a vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neural tissues. The NuVasive® Mesh is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft material may be used at the surgeon's discretion.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ***_*** OR Over-The-Counter Use **_**
(Per 21 CFR 801.109)

*Division Sign-Off*

K023319