NUVASIVE TRIAD FACET SCREW SYSTEM

K020411 · Nuvasive, Inc. · MRW · Mar 12, 2002 · OR

Device Facts

• Record ID: K020411
• Device Name: NUVASIVE TRIAD FACET SCREW SYSTEM
• Applicant: Nuvasive, Inc.
• Product Code: MRW · OR
• Decision Date: Mar 12, 2002
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The NuVasive™ Triad™ Facet Screw System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. The NuVasive™ Triad™ Facet Screw System is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels, from C2 to S1 for the 3.5mm screws, and from L1 to S1 for the 4.5mm screws. The Triad™ Facet Screw System is indicated for treatment of any or all of the following: (a) pseudoarthrosis and failed previous fusion; (b) spondylolisthesis; (c) spondylolysis; (d) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies; (e) degeneration of the facets with instability; and (f) fracture. The NuVasive™ Triad™ Facet Screw System is intended for conventional or percutaneous surgical placement.

Device Story

Triad™ Facet Screw System consists of broad-headed, partially threaded titanium alloy (Ti-6Al-4V) screws and optional washers; designed for posterior insertion through facet joints into pedicles; provides bilateral immobilization to aid spinal fusion; utilizes lag technique for joint compression; washers distribute forces and maintain contact area. Used by surgeons in conventional or percutaneous spinal procedures. Device stabilizes spine, addressing instability and pain associated with degenerative conditions or fractures.

Clinical Evidence

No clinical data.

Technological Characteristics

Materials: Anodized titanium alloy (Ti-6Al-4V). Design: Broad-headed, partially threaded screws; optional washers; cannulated design available. Function: Posterior facet fixation/immobilization. Energy source: None (mechanical).

Indications for Use

Indicated for patients requiring bilateral facet fixation (with/without bone graft) at single/multiple levels (C2-S1 for 3.5mm screws; L1-S1 for 4.5mm screws) for pseudoarthrosis, failed fusion, spondylolisthesis, spondylolysis, degenerative disc disease, facet degeneration with instability, or fracture.

Predicate Devices

• NuVasive™ Percutaneous Transfacet/Intrapedicular Screw

Submission Summary (Full Text)

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020411

NuVasive™, Inc.

Special 510(k) Premarket Notification Triad™ Facet Screw System

# MAR 1 2 2002

## VII. 510(k) Summary

In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular §807.92, the following summary of information is provided:

#### A. Submitted by:

Laetitia Bernard Manager of Regulatory Affairs and Quality Assurance NuVasive™, Incorporated 10065 Old Grove Road San Diego, California 92131 Telephone: [phone] Telefacsimile: [phone]

#### Device Name B.

Trade Name: NuVasive™ Triad™ Facet Screw System Common or Usual Name: Posterior Facet Screw and Washer Facet Screw Spinal Device System Classification Name:

#### Predicate Devices C.

The subject NuVasive™ Triad™ Facet Screw System is substantially equivalent to the NuVasive™ Percutaneous Transfacet/Intrapedicular Screw currently manufactured and distributed commercially in the U.S. by NuVasive™, Inc.

#### D. Device Description

The NuVasive™ Triad™ Facet Screw System consists of broad-headed, partially threaded screws designed to compact juxtaposed facet articular processes to enhance spinal fusion The non-threaded portion facilitates compression of the joint surfaces and stability. through a lag technique. Washers may be used to complement the screws by helping distribute forces and maintain consistent contact area when the screws are angled relative to the bone surface. The screws and washers are fabricated from anodized titanium alloy (Ti-6Al-4V) and are supplied in various sizes.

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### Nu VasiveTM, Inc.

#### E. Intended Use

The NuVasive™ Triad™ Facet Screw System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. The NuVasive™ Triad™ Facet Screw System is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels, from C2 to S1 for the 3.5mm screws, and from L1 to S1 for the 4.5mm screws. The Triad™ Facet Screw System is indicated for treatment of any or all of the following:

- (a) pseudoarthrosis and failed previous fusion;
- (b) spondylolisthesis;
- (c) spondylolysis;
- (d) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies;
- (e) degeneration of the facets with instability; and
- (i) fracture.

The NuVasive™ Triad™ Facet Screw System is intended for conventional or percutaneous surgical placement.

#### Comparison to Predicate Devices F.

As was established in this submission, the subject device is substantially equivalent to the NuVasive™ Percutaneous Transfacet/Intrapedicular Screw cleared by the agency for commercial distribution in the United States.

Engineering drawings and labeling have demonstrated that the subject device is equivalent to the original device in terms of design, materials of composition, manufacturing, packaging, indications for use, and method of use, excepting only the fact that it may be implanted in conjunction with a washer, and may be available in a cannulated design in specific sizes.

Due to this equivalency, the device raises no new safety or effectiveness issues.

#### Summarv of Design Control Activities G.

Design control activities employed to control the development of the modification to the NuVasive™ Transfacet/Intrapedicular Screw included:

- a comprehensive Risk Analysis to identify potential risks and failures associated with . operation of the device, any mitigations incorporated to reduce or eliminate those risks and failures, and an assessment of residual risk;
- a comprehensive program of verification and validation activities demonstrating that . acceptance criteria were met, and that design output satisfied design input.

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020411

NuVasive™, Inc.

#### H. Summary of Clinical Tests

(Not applicable.)

#### Conclusions I.

The subject device is substantially equivalent to the currently marketed predicate device, and its development has been adequately and appropriately conducted and validated under a comprehensive design control program complying with Title 21 CFR, §820.30.

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes representing health, human services, and prevention. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

MAR 1 2 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Laetitia Bernard Manager of Regulatory Affairs and Quality Assurance NuVasive™, Incorporated 10065 Old Grove Road San Diego, California 92131

K020411 Re:

Trade/Device Name: NuVasive™ Triad™ Facet Screw System_ Regulatory Number: unclassified Regulation Name: N/A Regulatory Class: II Product Code: MRW Dated: February 6, 2002 Received: February 7, 2002

Dear Ms. Bernard:

We have reviewed your Section 510(k) 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 devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to provices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Laetitia Bernard

This letter will allow you to begin marketing your device as described in your 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 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its tollfree number [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Mark N Millar

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

Enclosure

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## NüVasive™, Inc.

page 1 of 1

#### Indications for Use Statement D.

510(k) Number (if known):

Device Name: Triad™ Facet Screw System

Indications for Use:

The NuVasive™ Triad™ Facet Screw System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. posteriorry unrough the superies Screw System is indicated for bilateral facet fixation, with The Nu Vasive - Triaa - Prace Devels, from C2 to S1 for the 3.5mm screws, and or williout oone grait, a crews. The Triad™ Facet Screw System is indicated for treatment of any or all of the following:

- (a) pseudoarthrosis and failed previous fusion;
- (b) spondylolisthesis;
- (c) spondylolysis;
- (d) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies;
- (e) degeneration of the facets with instability; and
- (g) fracture.

The NuVasive™ Triad™ Facet Screw System is intended for conventional or percutaneous surgical placement.

e. Mark n Milliman

of General, Restorativ and Neurological Devices

510(k) Number_

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

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

020411