LANX ANTERIOR CERVICAL PLATE SYSTEM

K050774 · Lanx, LLC · KWQ · Apr 11, 2005 · Orthopedic

Device Facts

• Record ID: K050774
• Device Name: LANX ANTERIOR CERVICAL PLATE SYSTEM
• Applicant: Lanx, LLC
• Product Code: KWQ · Orthopedic
• Decision Date: Apr 11, 2005
• 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 C1 and C6.

Device Story

Anterior cervical plate system; provides temporary stabilization of anterior spine during bony fusion. Anatomically curved metallic plates; titanium alloy construction. Used in surgical setting by surgeons. Device implanted to provide structural support to vertebrae; facilitates healing in patients with degenerative disc disease, trauma, tumors, or deformity. Output is mechanical stabilization of spinal segments. Benefits patient by maintaining alignment and stability while bone fusion occurs.

Clinical Evidence

Bench testing only. Fatigue and static testing performed according to engineering and scientific principles. Results demonstrate performance equivalent to previously cleared anterior cervical plates.

Technological Characteristics

Anatomically curved metallic plates; Titanium Alloy (ASTM F136-92, ISO 5832-3) and Titanium (ASTM F67 GR2-95, ISO 5832-2). 1-level to 5-level configurations; 18mm-118mm lengths. Manually applied locking mechanism. Non-sterile; requires steam autoclave sterilization (270°F/134°C for 30 minutes).

Indications for Use

Indicated for anterior interbody fixation of the cervical spine (C1-C6) for temporary stabilization during bony fusion in patients with degenerative disc disease, trauma (fractures), tumors, deformity (kyphosis, lordosis, scoliosis), pseudoarthrosis, or failed previous fusion. Contraindicated for screw attachment to posterior elements (pedicles) of 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 (K040401)

Submission Summary (Full Text)

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KOSO774

# APR 1 1 2005

| | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>. www.virtu.run |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Summary Information | LANX, LLC. |
| | |
| Premarket Notification, Section 510(k) | MARCH 21, 2005 |
| | |

Safe Medical Devices Act of 1990, 21 CFR 807.92 Regulatory Authority:

#### 1. Device Name:

Lanx Anterior Cervical Plate System Trade Name:

Common Anterior cervical spine system Name(s):

Classification Spinal intervertebral body fixation orthosis. Name(s):

### Establishment Name & Registration Number: 2.

| Name: | LANX, LLC. |
|---------|------------|
| Number: | 3004485144 |

### 3. Classification(s):

\$ 888.3060 Spinal intervertebral body fixation orthosis. (a) 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. (b) Classification. Class 11.

| Device Class: | Class II for all requested indications |
|-----------------------|----------------------------------------------|
| Classification Panel: | Orthopaedic and Rehabilitation Devices Panel |
| Product Code(s): | KWQ |

### Equivalent Predicate Device: 4.

LANX, LLC. believes that the Lanx Anterior Cervical Plate System is substantially equivalent to the following:

Equivalence can be seen in the design, material composition, surgical technique and intended use.

### 5. Device Description:

## General description of the new plate.

### Materials:

| Titanium Alloy | ASTM F136-92 | ISO 5832-3 |
|----------------|-----------------|------------|
| Titanium | ASTM F67 GR2-95 | ISO 5832-2 |

Cervical plates are offered for the following levels/configurations. These are offerings as detailed in the original submission.

One Level Two Level Three Level Four Level Five Level

### Cervical Special.doc

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Fatigue and static testing is complete. Samples were tested according to accepted Testing Summary. engineering and scientific principals. Test results demonstrate that the new plates perform in a manner equivalent to the previously cleared anterior cervical plates.

### Applicant Name & Address: 6.

Lanx, LLC 1155 Alpine Avenue, Suite 320 Boulder, CO 80304 303-443-7500 Fax: [phone] [e-mail]

#### 7. Company Contact:

Michael Fulton, M.D. Lanx. LLC 1155 Alpine Avenue, Suite 320 Boulder, CO 80304 303-443-7500 Fax: [phone] [e-mail]

### Submission Correspondent: 8.

Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, CA 94523-3389 925.356.2640 - 925.356.2654 - fax

#### 9. Performance Standards:

United States Food and Drug Administration mandated performance standards for this device do not exist. Various voluntary performance standards are utilized. Voluntary standards utilized include ASTM, Standard Operating Procedures, vendor & process certification procedures, Quality Systems Regulations, ISO materials standards and ISO 9000 series quality regulations.

LANX, LLC. also meets appropriate general controls authorized under Sections 501, 502, 518, 518, 519, and 520 of the Food, Drug, and Cosmetic Act.

### Storage, Packaging & Sterilization Information: 10.

The Lanx Anterior Cervical Plate System is supplied "NON-STERILE" and must be sterilized prior The recommended sterilization process is high temperature steam autoclave sterilization. The to use. referenced sterilization cycle produces a Sterility Assurance Level (SAL) of at least 10°

The validated cycle is: Method: Steam Gravity Cycle: Temperature: 270°F (134°C) Exposure Time: 30 minutes

All packages containing implants or instruments should be intact upon receipt. Damaged packaging may indicate the presence of unsafe product. If the package or product is damaged, the product should not be used and should be returned.

Cervical Special.doc

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Product must be handled, stored and opened in such a way that it is protected from inadvertent damage or I rough mused, the product must be placed into use following cleaning, sterilization and accepted surgical sterile technique.

| FEATURE | Lanx Anterior Cervical Plate System | Modified Anterior Cervical Plate. | SE? |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|-----|
| Indications for Use: | Temporary stabilization of the anterior spine while awaiting<br>bony fusion (healing) in patients with degenerative disc disease<br>(neck or radicular pain of discogenic origin with degeneration of<br>the disc confirmed by patient history and radiographic studies),<br>trauma (including fractures), tumors, deformity (kyphosis,<br>lordosis or scoliosis), or pseudoarthrosis and/or failed previous<br>fusion. | SAME | YES |
| Design: | Anatomically curved metallic plate | SAME | YES |
| Sterile: | No - Must be Autoclaved | SAME | YES |
| Plate Sizes: | 1-level to 5-level<br>18mm - 118mm length in 2-5mm increments | EQUIVALENT | YES |
| Material: | Titanium Alloy | SAME | YES |
| Locking<br>Mechanism: | Manually applied locking mechanism | Intergral locking mechanism - no intra-<br>operative assembly required | NO |
| Manufacturer: | Lanx, LLC | Lanx, LLC | YES |
| Product Code: | KWQ | KWQ | YES |
| K Number: | K040401 | Pending | YES |

### Summary Comparison Table: 12.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - U.S.A." is arranged in a circular pattern around the eagle.

APR 1 1 2005

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Lanx, LLC C/o Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, California 94523

Re: K050774

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 20, 2005 Received: March 25, 2005

Dear Mr. Schlerf:

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. David W. Schlerf

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 presticated 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 other general militiremational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Stup Rhodes
Miriam Provost, Ph.D.

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

Enclosure

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KOSO774

Page l

**510(k) Number**: K050774

Lanx Anterior Cervical Plate System Device Name(s):

## 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 C1 and C6.

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

Prescription Use OR Over-The-Counter Use PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)

Stypk Pluder

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

**510(k) Number** K050774

(Optional format 1-2-96)

(Per 21 CFR 801.109)

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