Terrace™ Anterior Cervical Plate System

K163104 · Corelink, LLC · KWQ · Jun 21, 2017 · Orthopedic

Device Facts

• Record ID: K163104
• Device Name: Terrace™ Anterior Cervical Plate System
• Applicant: Corelink, LLC
• Product Code: KWQ · Orthopedic
• Decision Date: Jun 21, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CoreLink TERRACE™ 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

The Terrace™ Anterior Cervical Plate System is a spinal fixation device used by surgeons to provide temporary stabilization of the anterior cervical spine during fusion procedures. The system consists of plates and screws provided in multiple sizes to accommodate varying patient anatomies. It is used in clinical settings for patients with conditions such as degenerative disc disease, trauma, tumors, or deformity. The device functions as a mechanical construct to support the spine during the healing process. It is provided non-sterile and requires sterilization by the healthcare facility prior to use.

Clinical Evidence

Bench testing only. Testing included static axial compression bending, static torsion, and dynamic axial compression bending fatigue per ASTM F1717-14, as well as corrosion testing per ASTM F2129. Results confirm the device is sufficient for its intended use.

Technological Characteristics

Materials: Ti-6Al-4V ELI (ASTM F136) and nitinol (ASTM F2063). Mechanical testing standards: ASTM F1717-14 (static/dynamic), ASTM F2129 (corrosion). Form factor: Anterior cervical plate and screw system. Sterilization: Provided non-sterile; requires facility-based sterilization.

Indications for Use

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

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® ACP System (K121514)
• Trestle Luxe ACP (K102820)
• Anterior Cervical Plating System (K100614)
• IRIS™ ACP (K130202)
• Struxxure (K133475)

Submission Summary (Full Text)

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

June 21, 2017

CoreLink, LLC % Mr. Kenneth C. Maxwell II Regulatory and Quality Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs. Colorado 80918

Re: K163104

Trade/Device Name: Terrace™ 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: June 12, 2017 Received: June 13, 2017

Dear Mr. Maxwell:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 Industry and Consumer Education at its toll-free 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Mark N. Melkerson -S

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

510(k) Number (if known) K163104

#### Device Name

Terrace™ Anterior Cervical Plate System

#### Indications for Use (Describe)

The CoreLink TERRACE™ 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.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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| Submitter's Name: | CoreLink, LLC |
|----------------------------|------------------------------------------------------------------|
| Submitter's Address: | 7911 Forsyth Blvd , Suite #200<br>St. Louis, MO 63105 |
| Submitter's Telephone: | 888.349.7808 |
| Contact Person: | Kenneth C. Maxwell II<br>Empirical Testing Corp.<br>719.291.6874 |
| Date Summary was Prepared: | 20 June 2017 |
| Trade or Proprietary Name: | Terrace™ Anterior Cervical Plate System |
| Common or Usual Name: | Appliance, Fixation, Spinal Intervertebral Body |
| Classification: | Class II per 21 CFR §888.3060 Device Classification |
| Product Code: | KWQ |
| Classification Panel: | Division of Orthopedic Devices |

# 510(K) SUMMARY

## DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The Terrace™ Anterior Cervical Plate System is indicated for one through five levels of fixation and are provided in multiple sizes to accommodate a variety of patient anatomies. Screws are provided in multiple sizes to accommodate a variety of patient anatomies. Implants are manufactured from Ti-6Al-4V ELI conforming to ASTM F136 and nitinol conforming to ASTM F2063. Implants are provided non-sterile with instructions for sterilization.

# INDICATIONS FOR USE

The CoreLink TERRACE™ 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.

The indications for use for the Terrace™ Anterior Cervical Plate System is similar to that of the predicate devices noted in Table 5-1.

| 510k | Trade or Proprietary or Model | Manufacturer | Predicate |
|---------|----------------------------------|---------------|------------|
| Number | Name | | Type |
| K121514 | ANODYNE® ACP System | CoreLink, LLC | Primary |
| K102820 | Trestle Luxe ACP | Alphatec | Additional |
| K100614 | Anterior Cervical Plating System | Orthofix | Additional |
| K130202 | IRIS™ ACP | Life Spine | Additional |
| K133475 | Struxxure | Next Spine | Additional |

### Table 5-1 Predicate Devices

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## PERFORMANCE DATA

The Terrace™ Anterior Cervical Plate System has been tested in the following test modes:

- Static axial compression bending per ASTM F1717-14 .
- Static torsion per ASTM F1717-14 ●
- Dynamic axial compression bending fatigue per ASTM F1717-14 ●
- . Corrosion testing per ASTM F2129

The results of this non-clinical testing show that the strength of the Terrace™ Anterior Cervical Plate System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

# TECHNOLOGICAL CHARACTERISTICS

The following characteristics are similar between the subject and predicate devices:

- Principles of Operations ●
- . Indications for Use
- Materials ●
- Sterility

# CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the Terrace™ Anterior Cervical Plate System is substantially equivalent to the predicate device.