Anterior Cervical Plate System

K151553 · Osteomed Implantes, Ltda · KWQ · Feb 10, 2016 · Orthopedic

Device Facts

• Record ID: K151553
• Device Name: Anterior Cervical Plate System
• Applicant: Osteomed Implantes, Ltda
• Product Code: KWQ · Orthopedic
• Decision Date: Feb 10, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in 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), spondylolisthesis, trauma (i.e. fractures or dislocations), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spinal stenosis

Device Story

System consists of cervical plates and self-tapping bone screws for anterior fixation to cervical spine; used by surgeons in clinical settings. Plates (22-110mm) attach to vertebral bodies via screws (3.85-4.25mm diameter; 8-20mm length). Plates feature vision ports for intraoperative visualization and bone graft fixation. Device provides temporary stabilization to facilitate spinal fusion. Surgeon selects appropriate plate length and screw size based on patient anatomy; implants are secured via anterior approach. Benefits include stabilization of spinal segments during fusion process.

Clinical Evidence

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

Technological Characteristics

Materials: Commercially pure titanium (ASTM F67) and titanium alloy (Ti6Al4V, ASTM F136). Mechanical fixation via self-tapping bone screws. Plates include vision ports. No software or energy source.

Indications for Use

Indicated for skeletally mature patients requiring temporary stabilization of the anterior cervical spine (C2-T1) as an adjunct to fusion. Conditions include degenerative disc disease, spondylolisthesis, trauma (fractures/dislocations), tumors, deformity (kyphosis, lordosis, scoliosis), pseudarthrosis, failed previous fusion, and spinal stenosis.

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

• Cervical Spine Locking Plate (CSLP) - Synthes (K031276/K030866/K000742/K000536/K945700)
• C-Tek MaxAn Anterior Cervical Plate System - Biomet Spine (K080646)
• UNIPLATE ANTERIOR CERVICAL PLATE, - DePuy (K042544 / K082273 / K100070)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three faces in profile, stacked on top of each other.

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

February 10, 2016

Osteomed Implantes, LTDA % Mr. J.D. Webb The OrthoMedix Group, Incorporated 1001 Oakwood Boulevard Round Rock, Texas 78681

Re: K151553

Trade/Device Name: 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: January 5, 2016 Received: January 8, 2016

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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/Resourcesfor You/Industry/default.htm. 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/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 yours,

# Lori A. Wiggins -S

for 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) K151553

Device Name Anterior Cervical Plate System

#### Indications for Use (Describe)

The Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in 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),

· spondylolisthesis,

- · trauma (i.e. fractures or dislocations),
- · tumors.
- · deformity (defined as kyphosis, lordosis, or scoliosis),
- · pseudarthrosis.
- · failed previous fusion,
- · spinal stenosis

| 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)

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| Date Prepared | June 5, 2015 |
|------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By | Osteomed Implantes, LTDA<br>Washington Luiz Road, km 172<br>Condomínio Conpark - Rua 6, S/N<br>CEP 13501-600<br>Rio Claro - SP<br>BRAZIL<br>(19) 3532-3411 Tele |
| 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] |
| Trade Name | Anterior Cervical Plate System |
| Common Name | anterior cervical plate |
| Classification Name | Spinal intervertebral body fixation orthosis |
| Class | II |
| Product Code | KWQ |
| CFR Section | 21 CFR section 888.3060 |
| Device Panel | Orthopedic |
| Primary Predicate<br>Device | Cervical Spine Locking Plate (CSLP) - Synthes (K031276/K030866/K000742/<br>K000536/K945700) |
| Additional Predicate<br>Devices | C-Tek MaxAn Anterior Cervical Plate System - Biomet Spine (K080646)<br>UNIPLATE ANTERIOR CERVICAL PLATE, - DePuy (K042544 / K082273 /<br>K100070) |
| Device Description | The Osteomed Implantes Anterior Cervical Plate System is intended for anterior<br>screw fixation of the plate to the cervical spine. The fixation construct consists of<br>a cervical plate that is attached to the vertebral body of the cervical spine with<br>self-tapping bone screws using an anterior approach. Plates are available in a<br>variety of lengths (22 mm - 110mm), addressing multiple levels of fixation (one to<br>six). The Osteomed plate incorporates holes or vision ports on the longitudinal<br>center line for intraoperative visualization and for screw fixation of bone graft.<br>Bone screws are available in two diameters (Ø3.85 mm and Ø4.25 mm) and a<br>variety of lengths (8mm - 20mm). |
| Materials | Commercially pure titanium conforming to ASTM F67<br>Titanium alloy (Ti6Al4V) conforming to ASTM F136 |
| Substantial<br>Equivalence Claimed<br>to Predicate Devices | The Anterior Cervical Plate 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 Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:<br>degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e. fractures or dislocations), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spinal stenosis |
| Non-clinical Test Summary | The following analyses were conducted: Static and dynamic compression per ASTM F1717 Static torsion per ASTM F1717 The results of these evaluations indicate that the Anterior Cervical Plate System is equivalent to predicate devices. |
| Clinical Test Summary | No clinical studies were performed |
| Conclusions: Non-clinical and Clinical | Osteomed Implantes considers the Anterior Cervical Plate System to be equivalent to the predicate device listed above. This conclusion is based upon the device's similarities in principles of operation, technology, materials, and indications for use |

### 510(k) Summary: Anterior Cervical Plate System

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