MANTA RAY ANTERIOR CERVICAL PLATE SYSTEM

{0}------------------------------------------------ K080690 APR 2 5 2008 ## 510(k) Summary (21 CFR Part 807.92) ## A. Submitter Information | Submitter's Name: | Theken Spine, LLC | |------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Address: | 1800 Triplett Blvd.<br>Akron, Ohio 44306 | | Telephone Number: | 330-475-8600 | | Fax Number: | 330-773-7697 | | Contact Person: | Dale Davison | | Date Prepared: | 03 March 2008 | | Trade Name: | Manta Ray™ Anterior Cervical Plate (ACP) System | | Common Name: | Anterior Spinal Fixation System | | Classification Name: | Spinal Intervertebral Body Fixation Orthosis (per 21 CFR 888.3060) | | Device Classification: | Class II (per 21 CFR 888.3060)<br>Panel: Orthopedic, Product Code: KWQ, Panel Code: 87 | | Material Composition: | Implant grade Titanium Alloy (Ti-6Al-4V ELI) per ASTM F136 | | Device Description: | The Manta Ray™ ACP System is an anterior cervical plate fixation system. The system consists of a number of plates and screws. The plates feature a normal lordotic curvature as well as a transverse plane curvature for anatomic fit and are available in a variety of lengths for one to four level configurations. Screws are available in fixed and variable angle styles to create rigid or semi-rigid constructs as well as multiple lengths to fit individual patient pathologies. All implants are machined from implant grade titanium alloy, Ti-6Al-4V (ELI) per ASTM F-136. | | Intended Use: | The Manta Ray™ ACP System is an anterior cervical plate that is intended for temporary stabilization of the cervical spine from C2-C7 due to the following indications: Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), Spondylolisthesis, Trauma (i.e. fracture/dislocation), Tumor, Spinal stenosis, Deformity (i.e. scoliosis, kyphosis and/or lordosis), Pseudoarthrosis, Failed previous fusion | | Performance Data: | Static and fatigue testing was performed to characterize the stiffness, strength and fatigue life of Manta Ray™ ACP System | | Predicate Device: | X-Spine Systems - Spider Cervical Plating System (K052292 - October 21, 2005)<br>Theken Surgical, LLC - Tether™ ACFS (K010466 - May 16, 2001) | ## C. Substantial Equivalence Theken Spine, LLC believes that the Manta Ray™ ACP System is substantially equivalent to Theren Spine, ELO believes that the Mana Ray - Stablishment of equivalence is based on the same other legally marketed predicate devices. Establishment of equivalence is be other legally marketed predicate devices. Establishment dies in design concept, the use of Infications and contrainuleations for use as woll as emilantical testing and engineering analysis. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white and appears to be a scanned image. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR 2 5 2008 Theken Spine % Mr. Dale Davison Vice President of Engineering 1800 Triplett Blvd Akron, OH 44306 K080690 Re: Trade/Device Name: Manta Ray™ Anterior Cervical Plate (ACP) System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: March 3, 2008 Received: March 11, 2007 Dear Mr. Davison: 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. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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. {2}------------------------------------------------ Page 2 - Mr. Dale Davison This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Mark M. Millman Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K080690 Device Name: Manta Ray ACP System Indications For Use: The Manta Ray™ ACP System is an anterior cervical plate that is intended for t ne manta + (a) = + (a) = + (a) = + (a) = = ) = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = - Degenerative Disc Disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) - Spondylolisthesis - Trauma (i.e. fracture/dislocation) - Tumor - Spinal stenosis - Deformity (i.e. scoliosis, kyphosis and/or lordosis) - Pseudoarthrosis - Failed previous fusion AND/OR × 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 ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1 __ Nuths. Ogl. for Ci. 223 (Division Sign-Division of General, Restorative, and Neurological Devices **510(k) Number** K080610