Ocata Anterior Cervical System

K170342 · Kalitec Direct, LLC · KWQ · May 9, 2017 · Orthopedic

Device Facts

• Record ID: K170342
• Device Name: Ocata Anterior Cervical System
• Applicant: Kalitec Direct, LLC
• Product Code: KWQ · Orthopedic
• Decision Date: May 9, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Maintain adequate disc space until fusion occurs.

Device Story

Ocata™ Anterior Cervical System is a spinal fixation implant set used by surgeons in clinical settings to provide temporary stabilization of the cervical spine during fusion. The system consists of titanium alloy bone plates and screws (fixed or variable, self-drilling or self-tapping) and associated surgical instruments. Surgeons use an anterior approach to insert screws into the vertebral body, securing the plate to maintain disc space and facilitate fusion. The device provides mechanical support to the spine; it does not involve electronic processing, software, or AI. Clinical benefit is derived from stabilizing the spinal segment to promote successful fusion in patients with degenerative, traumatic, or structural spinal conditions.

Clinical Evidence

No clinical data. Bench testing only. Mechanical testing included static and dynamic compression and torsion per ASTM F1717 for plates, and torsional yield strength, driving torque, and axial pullout strength per ASTM F543 for screws.

Technological Characteristics

Implants: Ti-6Al-4V ELI (ASTM F136). Instruments: 17-4 H900 SS or 465 SS H950 (ASTM F899). Mechanical fixation via bone screws and plates. No energy source, software, or connectivity.

Indications for Use

Indicated for anterior interbody screw fixation of the cervical spine (C2-T1) for temporary stabilization as an adjunct to fusion. Patient population includes those with degenerative disc disease, trauma (fractures/dislocations), tumors, spondylolisthesis, deformity (kyphosis, lordosis, scoliosis), spinal stenosis, pseudarthrosis, or failed previous fusions. Contraindicated for posterior element (pedicle) attachment.

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

• Theken Surgical Tether™ ACFS (K010466)
• Integra Sonoma™ Cervical Plate System (K032368)
• Stryker Reflex™ Anterior Cervical Plate System (K062310)
• Stryker Reflex™ Anterior Cervical Plate System (K040261)
• Synthes CLSP Cervical Plate (K000536)

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

May 9, 2017

Kalitec Direct, LLC % Mr. J.D. Webb Official Correspondent The Orthomedix Group. Inc. 1001 Oakwood Boulevard Round Rock, Texas 78681

Re: K170342

Trade/Device Name: Ocata™ Anterior Cervical System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWO Dated: January 31, 2017 Received: February 3, 2017

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

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

## Indications for Use

510(k) Number (if known)

#### K170342

Device Name

Ocata™ Anterior Cervical System

#### Indications for Use (Describe)

The Ocata™ Anterior Cervical System is intended for anterior interbody screw fixation of the cervical spine from C2 to T1. The system is indicated for use in the temporary stabilization of the anterior spine as an adjunct to fusion for patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures and dislocations), tumors, spondylolisthesis, deformity (defined as kyphosis, lordosis), spinal stenosis, pseudarthrosis, and/or failed previous fusions. This device system is intended for anterior cervical intervertebral body fusions only.

WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

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

ا Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Summary: Ocata™ Anterior Cervical System

| Date Prepared | January 31, 2017 |
|------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By | Scott Winn<br>Kalitec Direct, LLC<br>618 E. South Street, Suite 500<br>Orlando, FL 32801<br>407-545-2063 Tele<br>407-358-5441 Fax |
| Primary Contact | J.D. Webb<br>1001 Oakwood Blvd<br>Round Rock, TX 78681<br>512-388-0199 Tele<br>e-mail: [e-mail] |
| Secondary Contact | Keith Cannan<br>1890 W. CR 419, Suite 2000<br>Oviedo, FL 32765<br>407-545-2063 Tele<br>407-358-5441 Fax<br>e-mail: [e-mail] |
| Trade Name | Ocata™ Anterior Cervical System |
| Common Name | Anterior Cervical Plate System |
| Classification Name | Appliance, Fixation, Spinal Intervertebral Body |
| Class | II |
| Product Code | KWQ |
| CFR Section | 21 CFR section 888.3060 |
| Device Panel | Orthopedic |
| Primary Predicate<br>Device | Theken Surgical TetherTM ACFS – K010466 |
| Additional Predicate<br>Devices | Integra Sonoma™ Cervical Plate System - K032368<br>Stryker Reflex™ Anterior Cervical Plate System - K062310 and K040261<br>Synthes CLSP Cervical Plate – K000536 |
| Device Description | The Ocata Anterior Cervical System components are temporary implants that are<br>intended for anterior interbody screw fixation of the cervical spine during the development<br>of a cervical spinal fusion.<br>The Ocata Anterior Cervical System consists of a variety of shapes and sizes of bone<br>plates, screws (available in self-drilling or self-tapping, fixed or variable configurations),<br>and associated instruments.<br>Fixation is provided by bone screws inserted into the vertebral body of the cervical spine<br>using an anterior approach. The Ocata™ Anterior Cervical System implant components<br>are made from titanium alloy. |
| Materials | Implants are made from Ti-6Al-4V ELI conforming to ASTM F136.<br>System specific instruments are made from either 17-4 H900 SS or 465 SS H950<br>conforming to ASTM F899. |
| Intended Use | Maintain adequate disc space until fusion occurs. |
| Substantial<br>Equivalence Claimed<br>to Predicate Devices | The Ocata™ Anterior Cervical System is substantially equivalent to the predicate<br>devices in terms of intended use, design, materials used, mechanical safety and<br>performances. |
| Indications for Use | The Ocata ™ Anterior Cervical System is intended for anterior interbody screw fixation of<br>the cervical spine from C2 to T1. The system is indicated for use in the temporary<br>stabilization of the anterior spine as an adjunct to fusion for patients with degenerative disc<br>disease (as defined by neck pain of discogenic origin with degeneration of the disc<br>confirmed by patient history and radiographic studies), trauma (including fractures and<br>dislocations), tumors, spondylolisthesis, deformity (defined as kyphosis, lordosis, or<br>scoliosis), spinal stenosis, pseudarthrosis, and/or failed previous fusions. This device<br>system is intended for anterior cervical intervertebral body fusions only.<br>WARNING: This device is not approved for screw attachment to the posterior elements<br>(pedicles) of the cervical, thoracic, or lumbar spine. |
| Non-clinical Test<br>Summary | The following analyses were conducted:<br>Plates were tested for static and dynamic compression and torsion per ASTM F1717 Screws were tested for torsional yield strength, driving torque, and axial pullout strength per ASTM F543 The results of these evaluations indicate that the Ocata™ Anterior Cervical System is equivalent to predicate devices. |
| Clinical Test<br>Summary | No clinical studies were performed |
| Conclusions: Non-<br>clinical and Clinical | Kalitec Direct, LLC considers the Ocata™ Anterior Cervical System to be equivalent to the<br>predicate devices listed above. This conclusion is based upon the devices' similarities in<br>principles of operation, technology, materials and indications for use |

In accordance with 21 CFR 807.92 of the Federal Code of Regulations

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