SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

K132366 · Accel Spine · KWQ · Sep 3, 2013 · Orthopedic

Device Facts

• Record ID: K132366
• Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Applicant: Accel Spine
• Product Code: KWQ · Orthopedic
• Decision Date: Sep 3, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Degas Anterior Cervical Plate System is intended for anterior fixation to the cervical spine. The specific clinical indications include: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Device Story

Degas Anterior Cervical Plate System is a spinal intervertebral body fixation orthosis. System comprises main plates (20mm-110mm), screws (10mm-20mm, 3.5mm/4.0mm diameter), sub-plates, rivets, and instruments. Sub-plates pre-assembled to main plates to prevent screw back-out via elastic behavior during insertion. Components are color-anodized for identification. Used by surgeons in clinical settings for anterior cervical spine fixation. Provides mechanical stabilization to the cervical spine to facilitate fusion. Benefits include structural support for patients with degenerative, traumatic, or deformity-related spinal conditions.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Titanium alloy (Ti-6Al-4V ELI) per ASTM F136. Components: main plates, screws (fixed/variable, self-tapping/self-drilling), sub-plates, rivets. Non-sterile, single-use. Mechanical fixation via screw-plate assembly.

Indications for Use

Indicated for patients requiring anterior cervical spine fixation for degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, deformities (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or failed previous fusion.

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

• Dio Medical Rex Anterior Cervical Plate System (K121862)

Submission Summary (Full Text)

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K132366 ::: page 1 of 2

#

| SUBMITTED BY | Accel Spine<br>14901 Quorum Dr. Ste. 125<br>Dallas, TX 75254 | |
|------------------------------------------|---------------------------------------------------------------------------------------------------------|--------------|
| ESTABLISHMENT<br>REGISTRATION NUMBER | 3009051471 | |
| OWNER/OPERATOR<br>NUMBER | 10035914 | SEP 0 3 2013 |
| CONTACT PERSON | Aekta Patel<br>General Counsel<br>Accel Spine<br>Phone: [phone]<br>Fax: [phone] | |
| SUBMISSION PREPARED BY | Lisa Peterson<br>Kaedon Consulting, LLC<br>Email: [e-mail]<br>Phone: [phone] | |
| DATE PREPARED | July 24, 2013 | |
| CLASSIFICATION NAME | Spinal Intervertebral Body Fixation Orthosis | |
| DEVICE CLASS | Class II | |
| REGULATION NUMBER | 888.3060 (Product Code KWQ) | |
| COMMON NAME | Anterior Cervical Plate System | |
| PROPRIETARY NAME | Degas Anterior Cervical Plate System | |
| IDENTIFICATION OF PREDICATE<br>DEVICE(S) | Dio Medical Rex Anterior Cervical Plate System (K121862) | |

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# K132366 ::: page 2 of 2

# DEVICE DESCRIPTION

The Degas Anterior Cervical Plate System consists of a variety of shapes and sizes of main plates. screws, sub-plates, rivets and associated instruments. The sub-plate is pre-assembled to the main plate and designed to prevent screws from backing out using the elastic behavior during the screw insertion.

The rivets are pre-assembled to the main plate, which firmly attach the sub-plate component to the main plate. Each component is color anodized to differentiate the screw type and diameter and to facilitate the surgical process.

The plates range in length to accommodate one, two, three, and four level procedures. Main plates are available from 20mm to 110mm. Screws are available in lengths from 10mm to 20mm in 2mm increments. The screws have either a 3.5mm or 4.0mm diameter. They are provided in fixed self-tapping, variable self-tapping, fixed self-drilling and variable self-drilling configurations.

## INDICATIONS

The Degas Anterior Cervical Plate System is intended for anterior fixation to the cervical spine. The specific clinical indications include:

degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

# SUMMARY OF TECHNOLOGICAL CHARACTERISTICS

The purpose of this Special 510(k) is to obtain clearance to market the subject device as the Degas Anterior Cervical Plate System. The subject device was previously cleared as the Dio Medical Rex Anterior Cervical Plate System (K121862). Documentation the legal right to distribute the Degas Anterior Cervical Plate System is maintained at Accel Spine.

The subject device is identical to the previously cleared Rex System in terms of indications for use, device dimensions, instrumentation, manufacturing process, cleaning/sterilization process and labeling. The System implant components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136.

# DISCUSSION OF NON-CLINICAL TESTING

Non-clinical testing was not performed as part of this submission.

### CONCLUSIONS

The subject device is identical to the predicate device in terms of indications for use, device dimensions, instrumentation, manufacturing process, cleaning/sterilization process and labeling. Documentation was provided as part of this Special 510(k) to demonstrate that the Degas Anterior Cervical Plate System is substantially equivalent to the predicate device.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The HHS logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the caduceus symbol.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W066-G609 Silver Spring, MD 20993-0002

September 3, 2013

Accel Spine % Ms. Lisa Peterson Kacdon Consulting, LLC 14001 Hunters Pass Austin, Texas 78734

Re: K132366

Trade/Device Name: Degas 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: August 1, 2013 Received: August 7, 2013

Dear Ms. Peterson:

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. Iisting 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 cither 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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# Page 2 - Ms. Lisa Peterson

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic 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" (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 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 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): K132366

#### Device Name: Degas Anterior Cervical Plate System

Indications for Use:

The Degas Anterior Cervical Plate System is intended for anterior fixation to the cervical spine. The specific clinical indications include:

degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anton E. Dmitriev, PhD Division of Orthopedic Devices