CYCLONE ANTERIOR CERVICAL PLATE SYSTEM

{0}------------------------------------------------ SEP 2 3 2003 # 510(k) Summary of Safety and Effectiveness 031214 page 1 of 1 - (1) Submitter's name: Submitter's address: Submitter's telephone number: Contact person: Date summary prepared: Encore Medical, L.P. 9800 Metric Blvd, Austin, TX 78758 (512) 834-6255 Debbie De Los Santos April 15, 2003 - Cyclone™ Anterior Cervical Plate Trade or proprietary device name: (2) Svstem Anterior Cervical Plate Common or usual name: 888.3060 - Spinal Intervertebral Body Classification name: Fixation Orthosis - Predicate devices: (3) Trinica Select Anterior Cervical Plate Zephir Anterior Cervical Plate #### (4) Subject device description: The Cyclone™ Anterior Cervical Plate System is a fixation device consisting of cervical plates (locking mechanism is pre-assembled to plates) and unicortical screws made from titanium alloy in conformance with ASTM F136. The plates are offered in one-level, two-level, and three-level fusion configurations (14mm-69mm). There are four different lengths of the standard 4mm diameter screw (12, 14, 16, and 18mm). The rescue screw has a diameter of 4.4mm and lengths are 12, 14 and 16mm. #### (5) Subiect device intended use: The Cyclone™ Anterior Cervical Plate System is intended to provide stabilization during the process of cervical spinal fusion (C2-C7) in patients with degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions. #### Basis for Substantial Equivalence: (6) The Cyclone™ Anterior Cervical Plate System is similar in design, indications and materials to Centerpulse Spine-Tech's Trinica Select Anterior Cervical Plate (K022344) and Medtronic Sofamor Danek's Zephir Anterior Cervical Plate (K994239). {1}------------------------------------------------ 510(k) Number (if known): __ Device Name: Indications For Use: ## Cyclone™ Anterior Cervical Plate System Indications For Use The Cyclone™ Anterior Cervical Plate System is intended for anterior Inter-body screw fixation to provide stabilization of cervical spinal fusion (C2-C7). This system is indicated for use in patients with degenerative disc disease (as defined by neck paln of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scollosis), pseudoarthrosis, and/or failed previous fusions. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use _____________________________________________________________________________________________________________________________________________________________ OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ KUZZIZIY {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/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 symbol that resembles an eagle or bird in flight, with stylized lines representing its wings and body. Public Health Service SEP 2 3 2003 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Debbie De Los Santos Supervisor. Regulatory/Clinical Services Encore Medical, L.P. 9800 Metric Boulevard Austin, TX 78758 Re: K031214 Trade/Device Name: Cyclone™ Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: April 16, 2003 Received: July 10, 2003 Dear Ms. De Los Santos: 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. {3}------------------------------------------------ ### Page 2 - Ms. Debbie De Los Santos 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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Mark N Millkum Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Cyclone™ Anterior Cervical Plate System Device Name: Indications For Use: ### Cyclone™ Anterior Cervical Plate System Indications For Use The Cyclone™ Anterior Cervical Plate System is intended to provide stabilization during the process of cervical spinal fusion (C2-C7) in patients with degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | Prescription Use | OR | Over-The-Counter Use | |----------------------|----|--------------------------| | (per 21 CFR 801.109) | | (Optional Format 1-2-96) | for (Division Sign-Off) Division of General, Restorative and Neurological Devices | 510(k) Number | K031214 | |---------------|---------| |---------------|---------|