NUVASIVE MESH

K020853 · Nuvasive, Inc. · EZX · Jun 13, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K020853
• Device Name: NUVASIVE MESH
• Applicant: Nuvasive, Inc.
• Product Code: EZX · General, Plastic Surgery
• Decision Date: Jun 13, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NuVasive® Mesh is indicated for use in the reinforcement of weak bony tissue in orthopedic procedures.

Device Story

NuVasive® Mesh is a surgical mesh device featuring a rhombic pattern; designed for reinforcement of weak bony tissue during orthopedic surgical procedures. Implant is available in preformed round or oval cylinders in various sizes. Device is used by surgeons in clinical settings. Substantial equivalence is claimed based on design, materials, and intended use compared to predicate surgical mesh systems.

Clinical Evidence

No clinical data.

Technological Characteristics

Rhombic pattern surgical mesh; metallic construction; preformed round or oval cylinder form factors; sterilization method not specified.

Indications for Use

Indicated for reinforcement of weak bony tissue in orthopedic procedures.

Regulatory Classification

Identification

Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

Predicate Devices

• Synthes® Synmesh™ System (K983766)
• Depuy-Motech™ Titanium Surgical Mesh (K900138)
• Sofamor Danek's Timesh™ System (K974017)
• Sofamor Danek's Pyramesh™ System (K973145)

Submission Summary (Full Text)

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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:

#### 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: March 14, 2002.

#### B. Device Name

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

NuVasive® Mesh Surgical Mesh Surgical Mesh

#### C. Predicate Devices

The subject device is substantially equivalent to the Synthes® Synmesh™ System (510([k] submission No. K983766), Depuy-Motech™ Titanium Surgical Mesh (510([k] submission No. K900138), and Sofamor Danek's Timesh™/ Pyramesh™ System (510([k] submission No. K974017/K973145).

#### D. Device Description

The NuVasive® Mesh is a rhombic pattern surgical mesh device intended for the reinforcement of weak bony tissue during orthopedic surgical procedures. The implant is available in preformed round or oval cylinders, in a variety of different sizes.

#### E. Intended Use

The NuVasive® Mesh is indicated for use in the reinforcement of weak bony tissue in orthopedic procedures.

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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 and labeling 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, including sterilization, and labeling.

## G. Summary of Non-Clinical Tests

(Not Applicable).

## H. Summary of Clinical Tests

(Not Applicable).

## I. Conclusions of Non-Clinical and Clinical Tests

(Not Applicable).

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## JUN 1 3 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K020853

Trade/Device Name: NuVasive® Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: EZX Dated: March 14, 2002 Received: March 15, 2002

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, 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). Other general information on your responsibilities under the Act may be obtained 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,

R. Mark N. Wilkerson

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

## A. Indications for Use

510(k) Number (if known): Ko20953

Device Name: NuVasive® Mesh

Indications for Use:

The NuVasive® Mesh is indicated for use in the reinforcement of weak bony tissue in orthopedic procedures.

Mark Millburn

Division of General, Restorative and Neurological Devices

510(k) Number -

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use OR