MODIFICATION TO: LANX ANTERIOR CERVICAL PLATE SYSTEM

K090316 · Lanx, Inc. · KWQ · Apr 7, 2009 · Orthopedic

Device Facts

• Record ID: K090316
• Device Name: MODIFICATION TO: LANX ANTERIOR CERVICAL PLATE SYSTEM
• Applicant: Lanx, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Apr 7, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Lanx Anterior Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The Lanx Anterior Cervical Plate System is suitable for use to provide temporary stabilization of the anterior spine while awaiting bony fusion (healing) in patients with degenerative disc disease (neck or radicular pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (kyphosis, lordosis or scoliosis), or pseudoarthrosis and/or failed previous fusion between and including levels C2 and C7. Warning: This device is not cleared for screw attachment to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Device Story

System consists of titanium alloy (Ti-6Al-4V ELI) plates and bone screws; provides temporary anterior cervical spine stabilization to support bony fusion. Used by surgeons in clinical settings for patients with degenerative disc disease, trauma, tumors, deformity, or failed prior fusion. Surgeon selects appropriate plate/screw sizes to construct fixation construct across C2-C7 levels. Device provides mechanical support; does not involve software or algorithms. Benefits include stabilization of spinal segments to facilitate healing.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Construct consists of anterior plates and bone screws. Material: implant grade titanium alloy (Ti-6Al-4V ELI). Mechanical fixation principle. Various sizes available for single or multi-level cervical spine application. No software or electronic components.

Indications for Use

Indicated for patients requiring anterior interbody fixation of the cervical spine (levels C2-C7) for temporary stabilization during bony fusion. Conditions include degenerative disc disease, trauma (fractures), tumors, deformity (kyphosis, lordosis, scoliosis), or pseudoarthrosis/failed fusion. Contraindicated for screw attachment to posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

Predicate Devices

• Lanx Anterior Cervical Plate System (K090316)

Submission Summary (Full Text)

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K090316
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# 510(k) SUMMARY Lanx Anterior Cervical Plate System

## Submitter Information

Lanx, Inc. 390 Interlocken Crescent, Suite 890 Broomfield, CO 80021 Contact Person: Andrew Lamborne Date Prepared: February 6, 2009

APR - 7 2009

# Device Identification

| Proprietary Name: | Lanx Anterior Cervical Plate System |
|-------------------|---------------------------------------------------------------|
| Common Name: | Anterior Cervical Plate System |
| Classification: | Spinal intervertebral body fixation orthosis, 21 CFR 888.3060 |

### Predicate Device Information

Lanx Anterior Cervical Plate System

### Intended Use / Indications for Use

The Lanx Anterior Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The Lanx Anterior Cervical Plate System is suitable for use to provide temporary stabilization of the anterior spine while awaiting bony fusion (healing) in patients with degenerative disc disease (neck or radicular pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (kyphosis, lordosis), or pseudoarthrosis and/or failed previous fusion between and including levels C2 and C7.

Warning: This device is not cleared for screw attachment to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

### Technological Characteristics

The Lanx Anterior Cervical Plate System consists of anterior plates and bone screws that are used to build a construct to provide stabilization of the anterior cervical spine to support fusion. The system contains plates and screws of various sizes that allow the surgeon to address single or multi-level cervical spine conditions. The material for components of the Lanx Anterior Cervical Plate System is implant grade titanium alloy (Ti-6Al-4V ELI).

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## Performance Data

Performance testing was conducted to characterize the modified system. The Lanx Anterior Cervical Plate met the acceptance criteria and functioned as intended.

16990316

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### Substantial Equivalence

The Lanx Anterior Cervical Plate System is as safe and effective as the predicate device. The Lanx Anterior Cervical Plate System has the same or similar intended use, indications, technological characteristics and principles of operation as the predicate device. The minor differences between the Lanx Anterior Cervical Plate System and its predicate device do not raise new issues of safety or effectiveness. Mechanical testing also demonstrated comparable mechanical properties to previously cleared devices. Thus, the Lanx Anterior Cervical Plate System is substantially equivalent to the predicate device.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged in a circle around the eagle. The eagle is depicted in black and white, and the text is also in black. The logo is simple and recognizable, and it is often used on official documents and websites related to the Department of Health & Human Services.

Food and Drug Administration

9200 Corporate Boulevard

Public Health Service

Rockville MD 20850

Lanx, Inc. % Mr. Andrew Lamborne 390 Interlocken Crescent, Suite 890 Broomfield, Colorado 80021

APR - 7 2009

Re: K090316

Trade/Device Name: Lanx Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: March 9, 2009 Received: March 10, 2009

Dear Mr. Lamborne:

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 - Mr. Andrew Lamborne

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson for mom

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K090316
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### Indications for Use Statement

510(k) Number (if known):

1090316

Device Name: Lanx Anterior Cervical Plate System

Indications for Use:

The Lanx Anterior Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The Lanx Anterior Cervical Plate System is suitable for use to provide temporary stabilization of the anterior spine while awaiting bony fusion (healing) in patients with degenerative disc disease (neck or radicular pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (kyphosis, lordosis or scoliosis), or pseudoarthrosis and/or failed previous fusion between and including levels C2 and C7.

Warning: This device is not cleared for screw attachment to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

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)

Aboulina Onuchm
(Division Sign-Off) for WM
Page **_ of _**

Division of General, Restorative, and Neurological Devices

**510(k) Number** 1<0903/6