PRIMALOK FACET FIXATION SYSTEM

K102438 · Osteomed LP · MRW · Sep 30, 2010 · OR

Device Facts

• Record ID: K102438
• Device Name: PRIMALOK FACET FIXATION SYSTEM
• Applicant: Osteomed LP
• Product Code: MRW · OR
• Decision Date: Sep 30, 2010
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The PrimaLOK™FF Facet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. It is intended for use with or without bone graft, at a single or multiple levels from L1 to S1 inclusive. It is indicated for the posterior surgical treatment of any or all of the following: degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, degenerative disease of the facets with instability, trauma (i.e., fracture or dislocation), spondylolisthesis, spondylolysis, and pseudarthrosis and failed fusions which are symptomatic or which may cause secondary instability or deformity. For transfacet fixation, the screws are inserted through the inferior articular process across the facet joint and into the pedicle. For translaminar facet fixation, the screws are inserted through the lateral aspect of the spinous process, through the lamina, through the inferior articular process, across the facet joint and into the pedicle.

Device Story

PrimaLOK™FF Facet Fixation System; partially threaded, cannulated, self-tapping 4.5mm titanium/titanium alloy screws with articulating washer. Used by surgeons in posterior spinal procedures; transfacet or translaminar insertion through facet joint into pedicle. Washer provides integral resistance to backout. Stabilizes spine to aid fusion; treats degenerative disc disease, instability, trauma, spondylolisthesis, spondylolysis, and pseudarthrosis. Benefits patient via immobilization of facet joints to address symptomatic instability or deformity.

Clinical Evidence

Bench testing only. Static and dynamic cantilever bending (modified ASTM F2193) and axial pullout tests (ASTM F543) performed to characterize mechanical properties and demonstrate substantial equivalence to predicate devices.

Technological Characteristics

Partially threaded, cannulated, self-tapping 4.5mm screw with articulating washer. Materials: Titanium and Ti-6Al-4V alloy per ASTM F67 and F136. Lengths: 25-45mm. Features integral backout resistance mechanism. Mechanical testing per ASTM F2193 and F543.

Indications for Use

Indicated for patients requiring spinal stabilization as an aid to fusion at levels L1-S1. Conditions include degenerative disc disease, facet joint degeneration with instability, trauma (fracture/dislocation), spondylolisthesis, spondylolysis, pseudarthrosis, and failed fusions.

Predicate Devices

• Discovery® Facet Screw (K012773)
• Chameleon™ Fixation System (K071420)
• PERPOS™ PLS System, BONE-LOK® Implant (K082795)

Submission Summary (Full Text)

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K102438

in

| 8. 510(k) Summary | | |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Date: | 23 August 2010 | SEP 30 2010 |
| Sponsor: | OsteoMed Spine Inc.*<br>3885 Arapaho Road<br>Addison, TX 75001 | |
| | Phone: [phone]<br>Fax: [phone]<br>* wholly owned subsidiary of OsteoMed LP | |
| Contact Person: | Rebecca Ellis, Vice President, RA/QA & Organizational Excellence | |
| Proposed Trade<br>Name: | PrimaLOK™FF Facet Fixation System | |
| Device Classification | Unclassified, Pre-Amendment | |
| Classification Name: | Facet screw spinal device system | |
| Regulation: | - | |
| Device Product<br>Code: | MRW | |
| Device Description: | The PrimaLOK™FF Facet Fixation System is a partially threaded,<br>cannulated, self-tapping 4.5mm screw having an assembled,<br>articulating washer. It is available in lengths from 25 to 45mm to<br>accommodate differing anatomic requirements. | |
| Intended Use: | The PrimaLOK™FF Facet Fixation System is intended to stabilize the<br>spine as an aid to fusion through bilateral immobilization of the facet<br>joints. It is intended for use with or without bone graft, at a single or<br>multiple levels from L1 to S1 inclusive. It is indicated for the posterior<br>surgical treatment of any or all of the following: degenerative disc<br>disease (DDD) as defined by back pain of discogenic origin with<br>degeneration of the disc confirmed by history and radiographic<br>studies, degenerative disease of the facets with instability, trauma<br>(i.e., fracture or dislocation), spondylolisthesis, spondylolysis, and<br>pseudarthrosis and failed fusions which are symptomatic or which<br>may cause secondary instability or deformity. For transfacet fixation,<br>the screws are inserted through the inferior articular process across<br>the facet joint and into the pedicle. For translaminar facet fixation, the<br>screws are inserted through the lateral aspect of the spinous<br>process, through the lamina, through the inferior articular process,<br>across the facet joint and into the pedicle. | |
| Materials: | The PrimaLOK™FF Facet Fixation System components are<br>manufactured from titanium and titanium alloy (Ti-6Al-4V) as<br>described by ASTM F67 and F136, respectively. | |
| Predicate Devices: | Discovery® Facet Screw (DePuy AcroMed, K012773)<br>Chameleon™ Fixation System (Spine Frontier, Inc. - K071420)<br>PERPOS™ PLS System, BONE-LOK® Implant (Interventional Spine,<br>Inc. - K082795) | |

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## Technological Characteristics:

The PrimaLOK™FF Facet Fixation System possesses the same technological characteristics as one or more of the predicates. These include:

- . basic design: partially threaded, cannulated screw with washer,
- material: titanium and/or titanium alloy, .
- sizing: sizes (diameter and lengths) are within the range of those . offered in the predicate systems, and
- intended use: as described above .

The PrimaLOK™ Facet Fixation System possesses a modified technological characteristic in that the assembled washer incorporates an integral feature which provides resistance to backout.

Therefore the fundamental scientific technology of the PrimaLOK™FF Facet Fixation System is the same as previously cleared devices.

## Performance Data:

Static and dynamic cantilever bending (modified ASTM F2193) and axial pullout tests (ASTM F543) were used to characterize the mechanical properties of the PrimaLOK™FF Facet Fixation System. The results demonstrated that the PrimaLOK™FF Facet Fixation System is substantially equivalent to predicate device performance.

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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 features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle in a circular fashion.

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

Osteomed L.P. % BackRoads Consulting, Inc. Karen E. Warden, Ph.D. 8202 Sherman Road Chesterland, OH 44026-2141

SEP 3 0 2010

Re: K102438

> Trade Name: PrimaLOK™ FF Facet Fixation System Regulatory Class: Unclassified Product Code: MRW Dated: August 26, 2010 Received: August 27, 2010

Dear Dr. Warden:

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 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Karen E. Warden, Ph.D.

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Far Dho
OEP

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

Enclosure

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K102438

## · 7. Indications for Use Statement

510(k) Number: K102438

SEP 30 2010

Device Name: PrimaLOK™FFFFFFFFFFFFFFFFFFFFFFFF

Indications for Use:

The PrimaLOK™EF Facet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. It is intended for use with or without bone graft, at a single or multiple levels from L1 to S1 inclusive.

It is indicated for the posterior surgical treatment of any or all of the following: degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, degenerative disease of the facets with instability, trauma (i.e., fracture or dislocation), spondylolisthesis, spondylolysis, and pseudarthrosis and failed fusions which are symptomatic or which may cause secondary instability or deformity.

For transfacet fixation, the screws are inserted through the inferior articular process across the facet joint and into the pedicle. For translaminar facet fixation, the screws are inserted through the lateral aspect of the spinous process, through the lamina, through the inferior articular process, across the facet joint and into the pedicle.

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

(21 CFR 807 Subpart C)

Over-the-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

KI02438 510(k) Number_