C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM

K080646 · Biomet Spine · KWQ · May 2, 2008 · Orthopedic

Device Facts

• Record ID: K080646
• Device Name: C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM
• Applicant: Biomet Spine
• Product Code: KWQ · Orthopedic
• Decision Date: May 2, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The C-Tek® MaxAnTM Anterior Cervical Plate System is intended for anterior interbody fixation of the cervical spine. Indications for use include the temporary stabilization of the anterior spine during the development of cervical fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin confirmed by patient history and radiographic studies), trauma including fractures, tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthroses, and/or failed previous fusions. The intended levels for treatment range from C2 - T1.

Device Story

C-Tek® MaxAn™ Anterior Cervical Plate System provides temporary anterior spinal stabilization during fusion. System comprises titanium alloy plates and screws (fixed/variable, 4.0-4.5mm diameter, 8-26mm length). Plates accommodate 1-6 levels (8-150mm length). Used by surgeons in clinical settings to fixate cervical vertebrae. Device provides mechanical support to facilitate bone fusion; benefits include stabilization of spine in patients with degenerative disease, trauma, or deformity. Output is physical fixation of spinal segments.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Titanium alloy (Ti-6Al-4V, ASTM F-136). System includes plates and screws (fixed/variable). Plates: 1-6 levels, 8-150mm. Screws: 4.0-4.5mm diameter, 8-26mm length. Sterile and non-sterile configurations.

Indications for Use

Indicated for patients requiring anterior cervical spine stabilization during fusion. Conditions include degenerative disc disease, trauma (fractures), tumors, deformity (kyphosis, lordosis, scoliosis), pseudarthroses, and failed previous fusions. Levels C2-T1.

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

• EBI Anterior Cervical Plate System (Cyprus Anterior Cervical Plating System) (K060379)
• EAGLE+ Anterior Cervical Plate system (K070994, K040197)
• Swift Plus Anterior Cervical Plate System (K072546, K040655)

Submission Summary (Full Text)

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K080646

MAY - 2 2008

Image /page/0/Picture/2 description: The image shows the logo for Biomet Spine. The word "BIOMET" is in a bold, sans-serif font, with each letter connected to the others. Below the word "BIOMET" is the word "SPINE" in a smaller, sans-serif font.

## 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.93

Biomet Spine Submitter: 100 Interpace Parkway Parsippany, NJ 07054 2242816 Establishment Registration Number: Jacquelyn A. Hughes, RAC Contact: Vice President, Quality/Clinical/Regulatory Affairs Biomet Spine 100 Interpace Parkway Parsippany, NJ 07054 Tel .: [phone], ext. 3075 Fax: [phone] Email: [e-mail] April 30, 2008 Date Prepared: C-Tek® MaxAn™ Anterior Cervical Plate System Trade/Proprietary Name: Spinal intervertebral body fixation orthosis Common/Usual Name: Appliance, Fixation, Spinal Intervertebral Body Classification Name: Class II, 21 CFR 5888.3060, KWQ Device Classification: EBI Anterior Cervical Plate System (Cyprus Anterior Cervical Predicate Device(s): Plating System), K060379 EAGLE+ Anterior Cervical Plate system, K070994, K040197 Swift Plus Anterior Cervical Plate System, K072546, K040655 The C-Tek® MaxAn™ Anterior Cervical Plate System consists of Device Description: titanium alloy plates and screws. Screws are provided in both fixed and variable versions in sizes 4.0 mm and 4.5 mm with lengths from 8-26 mm. Screws will be provided in both sterile and nonsterile configurations. Cervical plates are provided in both sterile and non-sterile configurations for 1 - 6 levels and in appropriate lengths from 8-150 mm. The C-Tek® MaxAn™ Anterior Cervical Plate System is intended Indications for Use: for anterior interbody fixation of the cervical spine. Indications for use include the temporary stabilization of the anterior spine during

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the development of cervical fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin confirmed by patient history and radiographic studies), trauma including fractures, tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthroses, and/or failed previous fusions. The intended levels for treatment range from C2 - T1.

## Materials:

Performance:

The C-Tek® MaxAn™Anterior Cervical Plate System is comprised of various sizes of plates and screws made from titanium alloy (Ti-6Al-4V, ASTM F-136)

The technological characteristics of the C-Tek® MaxAn™ Anterior Cervical Plate System are the same as, or similar to, the predicate devices. Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the devices are functional within the intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem that resembles an abstract caduceus or a symbol representing health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAY - 2 2008

Biomet Spine % Jacqueline A. Hughes, RAC Vice President, Quality/Clinical/Regulatory Affairs 100 Interpace Parkway Parsippany, NJ 07054

Re: K080646

Trade/Device Name: C-Tek® MaxAm™ Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: March 5, 2008 Received: March 6, 2008

Dear Ms. Hughes:

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 - Jacqueline A. Hughes, RAC

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 the reporting 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. Wilkinson

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

Enclosure

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## Indications for Use

510(k) Number (if known): K080646

Device Name: C-Tek® MaxAn™ Anterior Cervical Plate System Indications for Use:

The C-Tek® MaxAnTM Anterior Cervical Plate System is intended for anterior interbody fixation of the cervical spine. Indications for use include the temporary stabilization of the anterior spine during the development of cervical fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin confirmed by patient history and radiographic studies), trauma including fractures, tumors, deformity (defined as `kyphosis, or scollosis), pseudarthroses, and/or failed previous fusions. The intended levels for treatment range from C2 -T1.

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

Over-The-Counter Use NO (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)

Nylke Ople for rkrg
(Division Sign-Off)

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Division of General, Restorative, and Neurological Devices

**510(k) Number** K080646