Ozark(tm) Cervical Plate System

K172104 · K2m, Inc. · KWQ · Aug 23, 2017 · Orthopedic

Device Facts

• Record ID: K172104
• Device Name: Ozark(tm) Cervical Plate System
• Applicant: K2m, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Aug 23, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Ozark™ Cervical Plate System is indicated for use in anterior screw fixation to the cervical spine (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions (pseudarthrosis) and deformity (defined as scoliosis, kyphosis or lordosis).

Device Story

The Ozark Cervical Plate System is an anterior cervical plate system used for spinal fixation. It consists of one- to five-level plates and variable/fixed screws with self-tapping and self-starting tips. The device is used by surgeons in an operating room setting to provide stabilization of the cervical spine (C2-T1). By securing the plates and screws to the vertebral bodies, the system facilitates fusion and provides structural support for patients suffering from degenerative conditions, trauma, or deformities. The device is provided either sterile or non-sterile.

Clinical Evidence

Bench testing only. Mechanical testing of the constructs was performed according to ASTM F1717, including static and dynamic compression and static torsion, demonstrating performance equivalent to predicate devices.

Technological Characteristics

Implants manufactured from titanium alloy (ASTM F136 and ASTM F1472). System includes one- to five-level plates and variable/fixed screws with self-tapping/self-starting tips. Mechanical testing conducted per ASTM F1717.

Indications for Use

Indicated for anterior screw fixation to the cervical spine (C2-T1) in patients with degenerative disc disease, spondylolisthesis, trauma (fractures), spinal stenosis, tumors, pseudarthrosis, or spinal deformity (scoliosis, kyphosis, lordosis).

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

• Pyrenees Cervical Plate System (K152281)
• Zavation Cervical Plate System (K130030)
• SKYLINE® Anterior Cervical Plate System (K103491)
• VueLock® Anterior Cervical Plate System (K023133)
• Cervical Spine Locking Plate (CSLP) (K030866)

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

K2M Inc. % Karen E. Warden, PhD BackRoads Consulting, Inc. PO Box 566 12520 Heath Road Chesterland, Ohio 44026

August 23, 2017

Re: K172104

Trade/Device Name: Ozark™ Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWO Dated: July 11, 2017 Received: July 12, 2017

Dear Dr. Warden:

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

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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 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 Industry and Consumer Education (DICE) 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 (DICE) 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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

# 510(k) Number (if known)

## K172104

Device Name Ozark™ Cervical Plate System

#### Indications for Use (Describe)

Ozark™ Cervical Plate System is indicated for use in anterior screw fixation to the cervical spine (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions (pseudarthrosis) and deformity (defined as scoliosis, kyphosis or lordosis).

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

∑ Prescription Use (Part 21 CFR 801 Subpart D)

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

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

### FOR FDA USE ONLY

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

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

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# Section 8 - 510(k) Summary

| Date: | 11 July 2017 |
|------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | K2M Inc.<br>600 Hope Pkwy. SE<br>Leesburg, Virginia 20175<br>Phone: [phone] |
| Sponsor Contact: | Nancy Giezen |
| 510(k) Contact: | Karen E. Warden, PhD<br>BackRoads Consulting<br>PO Box 566<br>Chesterland, OH 44026<br>Office: 440.729.8457 |
| Trade Name: | Ozark™ Cervical Plate System |
| Common Name: | Anterior cervical plate system |
| Regulatory Class: | Class II |
| Classification Name,<br>Regulation, Product<br>Code: | Appliance, fixation, spinal intervertebral body, 888.3060, KWQ |
| Device Description: | The Ozark Cervical Plate System consists of variable and fixed screws<br>having self-tapping and self-starting tips, and one- through five-level plates.<br>The implants are offered both sterile and non-sterile. |
| Intended Use: | Ozark™ Cervical Plate System is indicated for use in anterior screw fixation<br>to the cervical spine (C2-T1) for the following indications: degenerative disc<br>disease (DDD) (defined as neck pain of discogenic origin with degeneration<br>of the disc confirmed by history and radiographic studies), spondylolisthesis,<br>trauma (including fractures), spinal stenosis and tumors (primary and<br>metastatic), failed previous fusions (pseudarthrosis) and deformity (defined<br>as scoliosis, kyphosis or lordosis). |
| Materials: | The Ozark Cervical Plate System implants are manufactured from titanium<br>alloy as described by ASTM F136 and ASTM F1472. |
| Primary Predicate: | Pyrenees Cervical Plate System (K2M - K152281) |
| Additional Predicates: | Additional: Zavation Cervical Plate System (Zavation LLC - K130030),<br>SKYLINE® Anterior Cervical Plate System (DePuy Spine Inc. - K103491,<br>VueLock® Anterior Cervical Plate System (Biomet Spine [nee EBI] -<br>K023133), Cervical Spine Locking Plate (CSLP) (Synthes Spine - K030866) |
| Performance Data: | Mechanical testing of the Ozark Cervical Plate System constructs was<br>performed according to ASTM F1717 and included static and dynamic<br>compression and static torsion.<br>The mechanical test results demonstrate that the Ozark Cervical Plate<br>System device performance is substantially equivalent to the predicate<br>devices. |
| Technological<br>Characteristics: | The Ozark Cervical Plate System possesses the same technological<br>characteristics as the predicate devices. These include:<br>design features,<br>●<br>material,<br>●<br>anatomic location and,<br>●<br>dimensional attributes.<br>●<br>Therefore the fundamental scientific technology of the Ozark Cervical Plate<br>System devices is the same as previously cleared devices. |

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The Ozark Cervical Plate System possesses the same intended use and Conclusion: technological characteristics as the predicate devices. Therefore the Ozark Cervical Plate System is substantially equivalent for its intended use.