3.8MM CS FACET COMPRESSION DEVICE

K052043 · Triage Medical, Inc. · MRW · Oct 17, 2005 · OR

Device Facts

• Record ID: K052043
• Device Name: 3.8MM CS FACET COMPRESSION DEVICE
• Applicant: Triage Medical, Inc.
• Product Code: MRW · OR
• Decision Date: Oct 17, 2005
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The intended use of the 3.8mm CS Facet Compression Device is to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The 3.8mm CS Facet Compression Device is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels from C2 to S1.

Device Story

3.8mm CS Facet Compression Device is a double-helix screw with a compression-locking collar, provided with or without a self-retaining washer. Device stabilizes spine as aid to fusion via bilateral immobilization of facet joints. Used by surgeons in clinical settings for spinal fixation procedures. Mechanical design provides compression across facet joints to facilitate fusion. Benefits include spinal stabilization in patients with degenerative conditions or instability.

Clinical Evidence

Bench testing only. Mechanical and biomechanical testing established that the device satisfies functional performance requirements and is safe for its intended use. No clinical data provided.

Technological Characteristics

Double-helix screw with compression-locking collar; optional self-retaining washer. Materials: Titanium 6Al-4V ELI (ASTM F-136) or surgical grade Stainless Steel (ASTM F-138). Mechanical fixation device.

Indications for Use

Indicated for patients with spondylolisthesis, spondylolysis, degenerative disc disease (DDD) (neck/back pain of discogenic origin confirmed by radiography), facet degeneration with instability and fracture, pseudoarthrosis, and failed previous fusion. Used for bilateral facet fixation at single or multiple levels from C2 to S1.

Predicate Devices

• NuVasive™ 3.5mm Triad™ Facet Screw System (K020411)

Submission Summary (Full Text)

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# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

#### SUBMITTER INFORMATION

| A. Company Name: | Triage Medical, Inc |
|-----------------------|-----------------------------------------------------------------|
| B. Company Address: | 13700 Alton Parkway<br>Suite 160<br>Irvine, CA 92618 |
| C. Company Phone: | [phone] |
| D. Company Facsimile: | [phone] |
| E. Contact Person: | Gayle Hirota<br>Manager, Quality Assurance & Regulatory Affairs |

### DEVICE IDENTIFICATION

| A. | Trade Name: | 3.8mm CS Facet Compression Device |
|----|----------------------|-----------------------------------------------------------------------------------------|
| B. | Catalog Number: | CS-38-1215 / CS-38-4050 (Titanium)<br>CSW -38-1215 / CSW-38-4050 (Titanium with Washer) |
| C. | Common Name: | Facet screw |
| D. | Classification Name: | Unclassified |
| E. | Product Code: | MRW |
| F. | Device Class: | Unclassified |

#### IDENTIFICATION OF PREDICATE DEVICE

The 3.8mm CS Facet Compression Device is similar in basic design, materials and intended use to the NuVasive™ 3.5mm Triad™ Facet Screw System cleared under 510(k) K020411.

#### DEVICE DESCRIPTION

The 3.8mm CS Facet Compression Device is a double-helix screw with a compressionlocking collar, and is provided with or without a self-retaining washer. It is available in various length ranges fabricated from either Titanium 6Al-4V, which meets the

CONFIDENTIAL

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requirements of ASTM F-136 or stainless steel, which meets the requirements of ASTM F-138.

# INTENDED USE

The intended use of the 3.8mm CS Facet Compression Device is to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The 3.8mm CS Facet Compression Device is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels from C2 to S1.

## TECHNOLOGICAL CHARACTERISTICS

The 3.8mm CS Facet Compression Device is similar in materials, design, construction and mechanical performance to the predicate devices.

# PERFORMANCE DATA (NON-CLINICAL)

Mechanical and biomechanical testing have established that the devices satisfies functional performance requirements and is safe when used as indicated.

# BIOCOMPATIBILITY

The 3.8mm CS Facet Compression Device is made from either Titanium 6Al-4V ELI, which meets the requirements of ASTM F-136 or surgical grade Stainless Steel, which meets the requirements of ASTM F-138. These materials are currently being utilized in a myriad of legally marketed orthopedic devices.

# CONCLUSIONS DRAWN FROM STUDIES

Documentation provided, and test results demonstrate that the 3.8mm CS Facet Compression Device is substantially equivalent to the predicate devices and is capable of safely and accurately performing the stated intended use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 17 2005

Gayle Hirota QA/RA Manager Triage Medical, Inc. 13700 Alton Parkway, Suite 160 Irvine, California 92618

Rc: K052043

Trade/Device Name: 3.8mm CS Facet Compression Device Regulation Number: Unclassified Regulation Name: N/A Regulatory Class: Unclassified Product Code: MRW Dated: September 20, 2005 Received: September 22, 2005

Dear Ms. Hirota:

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- Gayle Hirota

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" (21CFR 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/industry/support/index.html

Sincerely yours,

Mark N. Molkerson

Sor Mark N. Melkerson Acting 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

KOSZOY3 510(k) Number (if known):

3.8mm CS Facet Compression Device Device Name:

The 3.8mm CS Facet Compression Device is indicated Indications For Use: for spondylolisthesis, spondylolysis, degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies, degeneration of the facets with instability and fracture, pseudoarthrosis and failed previous fusion.

> The intended use of the 3.8mm CS Facet Compression Device is to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The 3.8mm CS Facet Compression Device is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels from C2 to SI.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Si. 00

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number_Ko 5 2043

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