ANODYNE ANTERIOR CERVICAL PLATE SYSTEM

K121514 · Corelink, LLC · KWQ · Dec 14, 2012 · Orthopedic

Device Facts

• Record ID: K121514
• Device Name: ANODYNE ANTERIOR CERVICAL PLATE SYSTEM
• Applicant: Corelink, LLC
• Product Code: KWQ · Orthopedic
• Decision Date: Dec 14, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

ANODYNE® Anterior Cervical Plate System provides temporary anterior spinal stabilization during fusion; indicated for C2-T1 levels. System consists of titanium alloy plates and screws; implanted by surgeons in clinical settings. Plates available in various lengths for 1-level to 4-level fixation; two-screw per level configuration. Device stabilizes spine to facilitate intervertebral fusion process; benefits patient by maintaining alignment during healing. No software or active components.

Clinical Evidence

Bench testing only. Performance evaluated via ASTM F1717 standards including static compression bending, static torsion, and dynamic compression bending. Finite Element Analysis also performed.

Technological Characteristics

Materials: Anodized Ti-6AI-4V ELI per ASTM F136. Components: Plates (13-100mm lengths) and screws. Configuration: Two-screw per level. Energy source: None (mechanical). Connectivity: None.

Indications for Use

Indicated for temporary anterior cervical spine stabilization during fusion in patients with degenerative disc disease, trauma (fractures), tumors, deformity (kyphosis, lordosis, scoliosis), pseudarthrosis, or 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

• Medtronic Atlantis (K993855)
• Medtronic Orion (K042235)
• Synthes Anterior CSLP System (K000742)
• Theken Tether (K010466)
• Depuy DOC (K982443)
• DePuy Uniplate Anterior Cervical Plate (K100070, K082273, and K042544)

Submission Summary (Full Text)

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# 510(k) Summary

## DEC 1 4 2012

| Contact: | Justin Eggleton<br>Musculoskeletal Clinical & Regulatory Advisers, LLC<br>1331 H Street NW, 12th Floor<br>Washington, DC 20005<br>202.552.5800 |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | December 14, 2012 |
| Device Trade Name: | ANODYNE® Anterior Cervical Plate System |
| Manufacturer: | Corelink, LLC<br>10805 Sunset Office Drive, Suite 300<br>St. Louis, MO 63127 |
| Common Name: | Spinal Fixation Device |
| Classification: | 21 CFR §888.3060; Spinal intervertebral fixation orthosis |
| Class: | II |
| Product Code: | KWQ |

#### Indications For Use:

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

#### Device Description:

The ANODYNE® Anterior Cervical Plate System is comprised of an assortment of titanium alloy plates and screws that act to stabilize the spine during the intervertebral fusion process. The ANODYNE® Anterior Cervical Plate System is manufactured from anodized Ti-6AI-4V ELI in accordance with ASTM F136. The two-screw per level plates are available in lengths of 13-30mm (1-level), 26-46mm (2-level), 46-70mm (3-level), and 60-100mm (4-level).

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#### Predicate Device(s):

The ANODYNE® Anterior Cervical Plate System was shown to be substantially equivalent to previously cleared devices and has the same indications for use, design, function, and materials used. These devices include the Medtronic Atlantis (K993855), Medtronic Orion (K042235), Synthes Anterior CSLP System (K000742), Theken Tether (K010466), Depuy DOC (K982443), and DePuy Uniplate Anterior Cervical Plate (K100070, K082273, and K042544).

#### Performance Standards:

Testing performed on this device indicates that the ANODYNE® Anterior Cervical Plate System is substantially equivalent to predicate devices. ASTM F1717 performance standards were adhered to and all applicable requirements were met. This testing included static compression bending, static torsion, and dynamic compression bending. Additional Finite Element Analysis was performed.

#### Conclusion:

The ANODYNE® Anterior Cervical Plate System is substantially equivalent to predicate devices with respect to safety and effectiveness.

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Public Health Service

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

Letter dated: December 14, 2012

Corelink. LLC % Musculoskeletal Clinical Regulatory Advisers Mr. Justin Eggleton Director, Spine Regulatory Affairs 1331 H Street Northwest, 12th Floor Washington, District of Columbia 20005

Re: K121514

Trade/Device Name: ANODYNE® Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: K WQ Dated: November 27, 2012 Received: November 30, 2012

Dear Mr. Eggleton:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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. Justin Eggleton

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/CDRHQffices/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/Safetv/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Mark N. Melkerson

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

51,0(k) Number (if known): _K121514

Device Name: ANODYNE® Anterior Cervical Plate System

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

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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### Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-off) Division of Orthopedic Devices 510(k) Number: K121514