ANODYNE ANTERIOR CERVICAL PLATE SYSTEM

K132994 · Corelink, LLC · KWQ · Dec 5, 2013 · Orthopedic

Device Facts

• Record ID: K132994
• Device Name: ANODYNE ANTERIOR CERVICAL PLATE SYSTEM
• Applicant: Corelink, LLC
• Product Code: KWQ · Orthopedic
• Decision Date: Dec 5, 2013
• 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, 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 stabilization of anterior cervical spine during fusion. System consists of titanium alloy plates and screws; features rotatable anti-backout locks for each screw position. Available in single and double plate configurations for 1-4 level treatments. Used by surgeons in clinical settings to stabilize spine segments C2-T1. Mechanical fixation supports bone healing process; prevents screw migration. Benefits include structural support during intervertebral fusion.

Clinical Evidence

No clinical data. Bench testing only: static and dynamic compression and static torsion per ASTM F1717.

Technological Characteristics

Materials: Ti-6Al-4V alloy (ASTM F136). Components: Cervical plates and screws with rotatable anti-backout locking mechanism. Plate lengths: 13-100mm. Screw diameters: 4.6mm or 5.2mm. Mechanical testing: ASTM F1717.

Indications for Use

Indicated for patients requiring temporary anterior cervical spine stabilization during fusion. Applicable for degenerative disc disease, trauma (fractures), tumors, deformity (kyphosis/scoliosis), pseudarthrosis, and failed previous fusions. Intended for 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

• Anodyne™ Anterior Cervical Plate System (K121514)
• UNIPLATE Anterior Cervical Plate System (K042544/ K082273/K100070)
• CSLP Anterior Cervical Plate (Synthes - K000536)

Submission Summary (Full Text)

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## 510(k) Summary for the Anodyne™ Anterior Cervical Plate System K132994/S001

In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the Anodyne™ Anterior Cervical Plate System

#### 1 -GENERAL INFORMATION

| Date Prepared: | December 02, 2013 | |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------|--------------|
| Trade Name: | Anodyne™ Anterior Cervical Plate System | |
| Common Name: | Anterior cervical plate | DEC 0 5 2013 |
| Classification Name: | Spinal intervertebral fixation orthosis | |
| Class: | II | |
| Product Code: | KWQ | |
| CFR section: | 21 CFR section 888.3060 | |
| Device panel: | Orthopedic | |
| Legally Marketed | Anodyne™ Anterior Cervical Plate System (K121514)<br>UNIPLATE Anterior Cervical Plate System (K042544/ K082273/K100070) | |
| Predicate Device: | CSLP Anterior Cervical Plate (Synthes - K000536) | |
| Submitter: | CoreLink, LLC<br>7606 Forsyth Blvd<br>Clayton, MO 63105 | |
| Contact: | J.D. Webb<br>1001 Oakwood Blvd<br>Round Rock, TX 78681<br>512-388-0199 Tele<br>512-692-3699 Fax<br>e-mail: [e-mail] | |

#### 2. DEVICE DESCRIPTION

The Anodyne™ Anterior Cervical Plate System is comprised of an assortment of cervical plates and screws that act to stabilize the spine during the intervertebral fusion process. The cervical plate has a rotatable anti-backout "lock" for each screw position to prevent back-out of the screw.

The plate is available in single and double plate configurations with multiple lengths ranging from 13 mm – 22 mm (1 level) and 26 mm – 40 mm (2 level) for the single plates. The double plates include 1 level (13 mm - 30 mm), 2 level (26 mm - 46 mm), 3 level (46 mm - 70 mm), and 4 level (60 mm -100 mm). The screws are available in various lengths from 12 mm - 20 mm, with major thread diameter options of 4.6 mm or 5.2 mm.

#### Change from Predicate:

This 510(k) is submitted in order to gain clearance for the single plate configuration.

#### Materials:

Ti-6Al-4V alloy per ASTM F136

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#### 3. SUBSTANTIAL EQUIVALENCE CLAIMED TO PREDICATE DEVICES

The Anodyne™ Anterior Cervical Plate System is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performances.

#### 4. 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, or scollosis), pseudarthrosis, and/or failed previous fusions. The intended levels for treatment range from C2 - T1.

#### 5. NON-CLINICAL TEST SUMMARY

The following tests were conducted:

- Static and dynamic compression per ASTM 1717 .
- Static torsion per ASTM F1717 .

The results of this testing indicate that the ANODYNE™ Anterior Cervical Plate System is equivalent to predicate devices.

#### 6. CLINICAL TEST SUMMARY

No clinical studies were performed

#### 7. CONCLUSIONS NONCLINICAL AND CLINICAL

CoreLink, LLC considers the ANODYNE™ Anterior Cervical Plate System to be equivalent to the predicate device listed above. This conclusion is based upon the devices' similarities of operation, technology, materials and indications for use.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

#### December 5, 2013

CoreLink, LLC % Mr. J.D. Webb OrthoMedix Group, Incorporated 1001 Oakwood Boulevard Round Rock. Texas 78681

Re: K132994

Trade/Device Name: Anodyne™ Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: October 7, 2013 Received: October 9, 2013

Dear Mr. Webb:

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. J.D. Webb

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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/Safety/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 -S

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

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

#### 510(k) Number (if known) K132994/S001

#### Device Name

#### Anodyne™ Anterior Cervical Plate System

#### Indications for Use (Describe)

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 degeneralive 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, defined as kyphosis, or scoliosis), pseudarthrosis, and/or failed previous fusions. The intended levels for treatment range from C2 - T1.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)