LANX FACET SCREW SYSTEM

K101364 · Lanx, Inc. · MRW · Aug 16, 2010 · OR

Device Facts

• Record ID: K101364
• Device Name: LANX FACET SCREW SYSTEM
• Applicant: Lanx, Inc.
• Product Code: MRW · OR
• Decision Date: Aug 16, 2010
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The Lanx Facet Screw System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from C2 to S1 for 3.5mm and 4.0mm screws and from L1 to S1 for 4.5mm screws. For transfacet fixation, the screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet, across the facet joint, and into the pedicle. The Lanx Facet Screw System is indicated for treatment of any or all of the following: - pseudoarthrosis and failed previous fusions which are symptomatic or which may cause secondary instability or deformity; - 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; - trauma including spinal fractures and/or dislocations.

Device Story

System consists of titanium alloy screws and washers; designed to compact facet articular processes to enhance spinal fusion and stability. Screws available in various diameters/lengths, partially or fully threaded, cannulated or non-cannulated. Used by surgeons in clinical settings for posterior spinal fixation via transfacet or translaminar approaches. Provides mechanical stabilization of facet joints to facilitate fusion; benefits patients by addressing instability and deformity associated with degenerative or traumatic spinal conditions.

Clinical Evidence

Bench testing only. Performance characterization included dynamic and static three-point bend (ASTM F1264-03), cantilever bend (ASTM F2193), and torsion/axial pull-out testing (ASTM F543). No clinical data presented.

Technological Characteristics

Materials: Medical grade titanium alloy (ASTM F136). Design: Cannulated/non-cannulated screws and washers. Mechanical testing standards: ASTM F1264-03, ASTM F2193, ASTM F543. No software or electronic components.

Indications for Use

Indicated for patients requiring spinal stabilization as an aid to fusion at levels C2-S1 (3.5/4.0mm screws) or L1-S1 (4.5mm screws). Conditions include pseudoarthrosis, failed fusions, spondylolisthesis, spondylolysis, degenerative disc disease, facet degeneration with instability, and spinal trauma/dislocations.

Predicate Devices

• NuVasive Facet Screw (K020411, K001323)
• Globus Corridor Fixation System (K083442)

Submission Summary (Full Text)

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#### 510(k) SUMMARY

#### Lanx Facet Screw System

#### Name of Firm and Contact

Lanx, Inc. 390 Interlocken Crescent, Suite 890 Broomfield, CO 80021 Phone: [phone] Contact Person: Michael Funk Date Prepared: May 13, 2010

AUG 1 6 2010

# Name of Device

Lanx Facet Screw System

## Common or Usual Name

Facet Screw System

# Classification

Unclassified, Product Code - MRW

## Predicate Device

NuVasive Facet Screw (K020411, K001323) Globus Corridor Fixation System (K083442)

#### Intended Use / Indications for Use

The Lanx Facet Screw System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from C2 to S1 for 3.5mm and 4.0mm screws and from L1 to S1 for 4.5mm screws. For transfacet fixation, the screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet, across the facet joint, and into the pedicle. The Lanx Facet Screw System is indicated for treatment of any or all of the following:

- pseudoarthrosis and failed previous fusions which are symptomatic or which may cause . secondary instability or deformity;

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- 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; ●
- . trauma including spinal fractures and/or dislocations.

#### Device Description

The Lanx Facet Screw System consists of various screws and washers designed to compact juxtaposed facet articular processes to enhance spinal fusion and stability. The screws are available partially threaded or fully threaded, cannulated or non-cannulated, and in various diameters and lengths to accommodate patient anatomy. Lanx Facet Screw System implants are fabricated from medical grade titanium alloy (per ASTM F-136).

# Performance Data

Performance testing and engineering analysis were conducted to characterize the performance of the Lanx Facet Screw System. Testing performed included dynamic and static three-point bend per ASTM F1264-03, cantilever bend per ASTM F2193, torsion and axial pull-out testing per ASTM F543. The device functioned as intended and the observed test results demonstrate substantial equivalence to the predicate devices.

#### Substantial Equivalence

The Lanx Facet Screw System has the same or similar intended use, indications, principles of operation, and technological characteristics as the predicate systems. Equivalency of this device is based on similarities in intended use, materials and design. Mechanical testing and engineering analysis demonstrated comparable mechanical properties to the predicate devices. Thus, the Lanx Facet Screw System is substantially equivalent to the predicate devices.

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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 stripes forming its wings and tail. The eagle is positioned above the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the eagle.

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

Lanx, Inc. % Mr. Michael Funk Director of Engineering, Lumbar 390 Interlocken Crescent, Suite 890 Broomfield, Colorado 80021

Re: K101364

Trade/Device Name: Lanx Facet Screw System Regulatory Class: Unclassified Product Code: MR W Dated: May 13, 2010 Received: May 19, 2010

Dear Mr. Funk:

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. Iisting 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 - Mr. Michael Funk

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,
Qaulage Bneem

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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## Indications for Use Statement

510(k) Number (if known): K101364

Device Name: Lanx Facet Screw System

Indications for Use:

The Lanx Facet Screw System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from C2 to S1 for 3.5mm and 4.0mm screws and from L1 to S1 for 4.5mm screws. For transfacet fixation, the screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet, across the facet joint, and into the pedicle. The Lanx Facet Screw System is indicated for treatment of any or all of the following:

- pseudoarthrosis and failed previous fusions which are symptomatic or which may cause � secondary instability or deformity;
- . 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;
- trauma including spinal fractures and/or dislocations. .

Prescription Use X (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)

(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

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