FACET SCREW SYSTEM

K130863 · Spinal USA · MRW · Aug 9, 2013 · OR

Device Facts

• Record ID: K130863
• Device Name: FACET SCREW SYSTEM
• Applicant: Spinal USA
• Product Code: MRW · OR
• Decision Date: Aug 9, 2013
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The Spinal USA Facet Screw System is intended to stabilize the spine as an aid to fusion by transfacet fixation. The device is indicated for posterior surgical treatment with or without bone graft, at single or multiple levels, of any or all of the following spinal levels L1 to S1 (inclusive): Spondylolisthesis, Spondylolysis, Pseudoarthrosis or failed previous which are symptomatic: Degenerative Disc Disease (DDD) as defined by back pain of discogenic origin with degeneration of disc confirmed by history and radiographic studies and/or degenerative disease of the facets with instability.

Device Story

Spinal USA Facet Screw System consists of titanium alloy screws for transfacet fixation; used to stabilize spine as aid to fusion. Implanted via posterior surgical approach at levels L1-S1. Screws available in various diameters/lengths to accommodate patient anatomy. Device provides mechanical stabilization of facet joint during fusion healing. Intended for use by surgeons in clinical/OR settings. Benefits include stabilization of spinal segments in patients with symptomatic degenerative conditions or instability.

Clinical Evidence

Bench testing only. Mechanical performance evaluated per ASTM F1264, including axial pullout, torque to failure, and static/dynamic 3-point bending. Results demonstrated performance comparable to predicate device, exceeding physiological loads and accepted criteria for spinal stabilization.

Technological Characteristics

Medical grade titanium alloy (ASTM F-136 and/or ISO 5832-3). Screw-based fixation system. Available in various diameters and lengths. Non-sterile. Mechanical performance validated via ASTM F1264 testing.

Indications for Use

Indicated for patients requiring posterior spinal stabilization (L1-S1) for symptomatic spondylolisthesis, spondylolysis, pseudoarthrosis, failed previous fusions, or degenerative disc disease/facet degeneration with instability. Used with or without bone graft.

Predicate Devices

• TranS1 Facet Screw (K073515)

Submission Summary (Full Text)

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| Date Summary Prepared: | July 5, 2013 |
|--------------------------------------------|--------------------------------------------------------------------------------------------|
| Submitter Information: | Spinal USA<br>2050 Executive Drive<br>Pearl, MS 39208 |
| Contact Name:<br>Phone:<br>Fax:<br>E-mail: | Charles Vassallo<br>601-420-4244<br>601-420-5501<br>[e-mail] |
| Device Trade Name: | Spinal USA Facet Screw System |
| Common Name: | Facet Screw System |
| Regulatory Number: | NA |
| Classification: | Unclassified |
| Product Code: | MRW |

#### INTENDED USE:

The Spinal USA Facet Screw System is intended to stabilize the spine as an aid to fusion by transfacet fixation. The device is indicated for posterior surgical treatment with or without bone graft, at single or multiple levels, of any or all of the following spinal levels L1 to S1 (inclusive): Spondylolisthesis, Spondylolysis, Pseudoarthrosis or failed previous which are symptomatic: Degenerative Disc Disease (DDD) as defined by back pain of discogenic origin with degeneration of disc confirmed by history and radiographic studies and/or degenerative disease of the facets with instability.

### DEVICE DESCRIPTION:

The Spinal USA Facet Screw System consists of a assortment of screws. Each are made of medical grade titanium alloy conforming to such standards as ASTM F-136 and/or ISO 5832-3. The screws will be provided non-sterile.

AUG 0 9 2013

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## MECHANICAL TESTING:

The Facet Screw System was mechanically tested per ASTM F1264. The objective of the tests where to test the Facet Screw System using the following test methods:

- Axial Pullout .
- Torque to Failure .
- . Static 3 - Point Bending
- Dynamic 3 Point Bending .

Conclusions of this testing demonstrated comparable mechanical performance to the predicate device tested in direct side by side testing. It further demonstrated strengths that exceed all physiological loads and accepted criteria along with spinal column through the facet joint with significant margin of safety provided. The Facet Screw System performed comparably to the commercially available predicate and demonstrated sufficient strength and fatigue resistance to stabilize the facet joint during fusion healing. Overall, the Facet Screw System performed well above the acceptance criteria and will adequately stabilize a fusion segment.

## EQUIVALENT DEVICE:

Documentation was provided which demonstrated the Facet Screw System to be substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in intended use, indications, anatomic sites, performance and material of manufacture.

The overall design of the Facet Screw System consists of screws. The screws are available in different diameters and lengths to accommodate patient anatomy and are substantially equivalent to the predicate devices.

#### PREDICATE DEVICE:

TranS1 Facet Screw, K073515

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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 that resembles a caduceus, which is a traditional symbol of medicine and healthcare.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 9, 2013

Mr. Charles Vassallo Senior Director of Quality and Regulatory Spinal United States of America 2050 Executive Drive Pearl, Mississippi 39208

Re: K130863

Trade/Device Name: Facet Screw System Regulatory Class: Unclassified Product Code: MR W Dated: July 11, 2013 Received: July 11, 2013

Dear Mr. Vassallo:

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. Ilisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you: however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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 - Mr. Charles Vassallo

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Erin | Keith

For

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

# K130863

Device Name: Facet Screw System

Indications for Use:

510(k) Number (if known):

The Spinal USA Facet Screw System is intended to stabilize the spine as an aid to fusion by transfacet fixation. The device is indicated for posterior surgical treatment with or without bone graft, at single or multiple levels, of any or all of the following spinal levels L1 to S1 (inclusive): Spondylolisthesis, Spondylolysis, Pseudoarthrosis or failed previous fusions which are symptomatic: Degenerative Disc Disease (DDD) as defined by back pain of discogenic origin with degeneration of disc confirmed by history and radiographic studies and/or degenerative disease of the facets with instability.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ColinFONEill

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K130863