LANX ANTERIOR CERVIAL PLATE SYSTEM

K040401 · Lanx, LLC · KWQ · Apr 12, 2004 · Orthopedic

Device Facts

• Record ID: K040401
• Device Name: LANX ANTERIOR CERVIAL PLATE SYSTEM
• Applicant: Lanx, LLC
• Product Code: KWQ · Orthopedic
• Decision Date: Apr 12, 2004
• Decision: SESE
• Submission Type: Traditional
• 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 cervical levels C2 and C7.

Device Story

Anterior cervical plate system; provides temporary stabilization of cervical spine (C2-C7) during bony fusion. Components include anatomically curved titanium plates, locking caps, and fixed/variable bone screws. Used by surgeons in clinical/OR settings. System implanted to provide structural support; maintains alignment while bone heals. Benefits patient by stabilizing spine, reducing pain, and correcting deformities. Device supplied non-sterile; requires high-temperature steam autoclave sterilization before use.

Clinical Evidence

Bench testing only. Fatigue and static testing of individual components and system configurations conducted per engineering principles. No clinical data provided.

Technological Characteristics

Materials: Titanium (ASTM F67 GR2-95, ISO 5832-2) and Titanium Alloy (ASTM F136-92, ISO 5832-3). Components: Plates (1-5 level), locking caps, fixed/variable bone screws (4.0mm/4.5mm). Sterilization: High-temperature steam autoclave (270°F/134°C, 30 min). Mechanical fixation via plate-screw construct.

Indications for Use

Indicated for patients requiring anterior cervical spine stabilization (C2-C7) due to 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

• Atlantis Anterior Cervical Plate System (K993855)

Submission Summary (Full Text)

{0}------------------------------------------------

KD40401

# APR 1 2 2004

| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>401611<br><br>Information<br>Summary . | | Comments of the store of the large of the large to the mail one mail one manaly shifting to response of the program and the program and the property of the program and the pr<br>A NIY |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Section 510(k)<br>" Premarket Notification __<br>Advanced the charles for the first of the first of the program promotion | | FEBRUARY 12 2004 |

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

#### 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):

#### 2. Establishment Name & Registration Number:

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

#### 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 eyetvpe screw. The cable is tightened with a tension device and it is fastened or crimped at each evetype 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 II.

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

#### 4. Equivalent Predicate Device:

LANX, LLC. believes that the Lanx Anterior Cervical Plate System is substantially equivalent to the following device system marketed by Sofamor/Danek of Memphis TN.

K993855, Atlantis Anterior Cervical Plate System, Sofamor/Danek.

The Sofamor/Danek brand cervical plates are cleared for marketing. The comparison device represents a cervical spinal instrumentation system and accessories that uses plates, screws, and other corresponding components, all of which are intended to be used for the surgical treatment of cervical spinal instability or deformity. Equivalence can be seen in the design, material composition, surgical technique and intended use.

#### Device Description: 5.

### General system description.

Materials. Materials for components of the Lanx Anterior Cervical Plate System are implant grade materials of titanium. The materials comply with applicable standards shown below.

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

{1}------------------------------------------------

### The system components include:

Instruments

Sterilizer trays

Locking caps

Cervical Plates One Level Two Level Three Level Four Level Five Level

Bone Screws - Fixed 4.0mm Self Drilling, Self Tapping 4.5mm Self Drilling, Self Tapping

## Bone Screws - Variable

4.0mm Self Drilling, Self Tapping 4.5mm Self Drilling, Self Tapping

Testing Summary. Fatigue and static testing of individual components as well as a typical system configuration were conducted. Samples were tested according to accepted engineering and scientific principals. Test results demonstrate that the Lanx Anterior Cervical Plate System performs in a manner equivalent to other existing anterior cervical plate systems.

#### 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]

#### 8. Submission Correspondent:

Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, CA 94523-3389 9.25.356.2640 - 925.356.2654 - fax

{2}------------------------------------------------

K040401

#### 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 and qualification 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, 510, 516, 518, 519, and 520 of the Food, Drug, and Cosmetic Act.

#### 10. Special Controls:

Special controls do not apply.

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

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

### The validated cycle is:

Miethod: Steam Cycle: Gravity 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.

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

#### 12. Summary Comparison Table:

| FEATURE | Lanx Anterior Cervical Plate System | Atlantis Anterior Cervical Plates. | SE? |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|-----|
| Indications for<br>Use: | Temporary stabilization of the anterior spine while awaiting<br>bony fusion (healing) in patients with degenerative disc<br>disease (neck or radicular pain of discogenic origin with<br>degeneration of the disc confirmed by patient history and<br>radiographic studies), trauma (including fractures), tumors,<br>deformity<br>(kyphosis,<br>lordosis<br>or<br>scoliosis),<br>or<br>pseudoarthrosis and/or failed previous 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 |
| Screw Sizes: | 4mm & 4.5mm dia. 10-25mm length in 1 mm increments | EQUIVALENT | YES |
| Material: | Titanium and Titanium Alloy | SAME | YES |
| Origin: | USA | USA | YES |
| Manufacturer: | Lanx, LLC | Sofamor/Danek | YES |
| Product Code: | KWQ | SAME | YES |
| K - Number: | Pending | K993855 | YES |

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/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 or feathers. The eagle is facing left. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 2 2004

Lanx, LLC C/o David W. Schlerf Buckman Company Incorporated 200 Gregory Lane, Suite C-100 Pleasant Hill. California 94523-3389

Re: K040401

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: February 12, 2004 Received: February 17, 2004

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 cnactment 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.

{4}------------------------------------------------

Page 2 -- 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 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 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 Manufacturers, International 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,

O Mula A. Millerson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

#### K040401 510(k) Number :

# Device Name(s): 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 cervical 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 | AND/OR | Over-The-Counter Use |
|-----------------------------|---|--------|------------------------|
| (Part 21 CFR 801 Subpart D) | | | (21 CFR 807 Subpart C) |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative,

and Neurological Devices

510(k) Number K040401

Page 1 of ____________________________________________________________________________________________________________________________________________________________________