SYNTHES CERVIFIX SYSTEM

{0}------------------------------------------------ ## Summary of Safety and Effectiveness Information [510(k) Summary] SYNTHES (U.S.A.) 1690 Russell Road Paoli, PA 19301 (610) 647-9700 Contact: Jonathan Gilbert 6/16/00 ### DEVICE Synthes CerviFix System consists of rods, plate/rods, hooks, clamps, screws, nuts and transconnectors. The implants are composed of the titanium alloy Ti6Al7Nb (ASTM F1295) or commercially pure grade 4 Titanium (ASTM F67). ### INDICATIONS ### Hooks, Plate/Rods, Rods and Screws When intended to promote fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, rod, hook and screw (3.2 mm cortex, 3.5 mm and 4.0 mm (occept 10), components of the Synthes CerviFix™ System are indicating for the following: - DDD (neck pain of discogenic origin with degeneration of the disc as ● confirmed by patient history and radiographic studies) - spondylolisthesis ● - spinal stenosis ● - fracture/dislocation . - atlantoaxial fracture with instability ● - occipitocervical dislocation . - revision of previous cervical spine surgery . - tumors ● When used to treat these cervical and occipitocervical conditions, these screws are limited to occipital fixation only. ### Hooks and Rods The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine. ### Rods, Clamps, Screws and Nuts The rods, clamps, screws and nuts are intended to promote fusion following reduction of fracture/dislocation or trauma in the upper thoracic spine (T1-T3). The use of these screws (3.5 mm, 4.0 mm cancellous and 3.5 mm, 4.2 mm cortex) is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine. The Synthes CerviFix™ System can also be linked to the Synthes Universal Spinal System using the 3.5 mm/6.0 mm parallel connectors from that system, and via the CerviFix tapered rods using lamina hooks, transverse process hooks, pedicle hooks, 4.2 mm screws, and the 5.0 mm/ 6.0 mm parallel connector. {1}------------------------------------------------ # CLASSIFICATION: CLASSIFICATION. The classification of the CerviFix System is Class II, as per the Code of Federal The Classincation of the Certific Dy50: Appliance, Fixation, Spinal, Interlaminal and Regulations, I the 21, Societererebral body fixation orthosis. The product code is KWP. The Panel code is 87. # BASIS OF SUBSTANTIAL EQUIVALENCE: DASHS OF SUBOTIC TENE & CerviFix system are similar to the components of The components of the Byraise of Pre-clinical testing shows the biomechanical previously cleared spinal systems. " The similar to the performance of previously cleared spinal systems with similar indications. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal are three stylized human profiles facing to the right. The profiles are stacked on top of each other and are connected by a series of curved lines. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # JUL 1 9 2001 Mr. Jonathan Gilbert Senior Regulatory Affairs Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli. Pennsylvania 19301 Re: K011969 Trade Name: Synthes CerviFix™ System Regulatory Number: 888.3050 Regulatory Class: Class II Product Code: KWP Dated: June 22, 2001 Received: June 25, 2001 Dear Mr. Gilbert: We have reviewed your Section 510(k) notification of intent to market the device referenced we have have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the stated in the energians ) to device Amendments, or to devices that have been reclassified in chaculient dait of the Federal Food, Drug, and Cosmetic Act (Act). 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, controls providents or active, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1 climation in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good 699. I I suobtainany orquirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to inspections, the Food and Drig Fring Fring result in regulatory action. In addition, FDA may publish comply with the GMT regularing your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {3}------------------------------------------------ Page 2 - Mr. Jonathan Gilbert This letter will allow you to begin marketing your device as described in your 510(k) premarket This letter will allow you to begin naketing your device of your device to a legally marketed notification. The FDA finding of substantial equivalence of your device to notification. The FDA finding of substantal equivaled of 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 and If you desire specific advice for your devices), please contact the (fice of Compliance at additionally 809.10 for in vitro diagnostic devices), please contact the of vour de additionally 809.10 for in vitro diagnostic concess, promotion and advertising of your device, (301) 594-4659. Additionally, for questions on the promotion and advertising o (301) 594-4659. Additionally, for questions on the process. Also, please note the regulation please contact the Office of Complance at (30) - 19-10-5. They CFR 807.97). Other general entitled, "Misbranding by reference to premarket notification the Division of Small entitled, "Misbranding by telefice under the Act may be obtained from the Division of Small information on your responsibilities under the Act may be obtained from the Divisi information on your responsibilities murber (800) 638-2041 or at (301) 443-6597, or at its Manufacturers Assistance at its toll-free 1115 to in the time Manufacturers 71ssilstairs =================================================================================================================================================== Sincerely yours, Sincerely yours, Osmtcheee rwo for 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}------------------------------------------------ ### Page 1 of 1 # 510(k) Number (if known): K011969_ ## Device Name: Synthes CerviFix System ### Indications for Use: ## Hooks, Plate/Rods, Rods and Screws Hooks, Tiale/Koas, Aous and Ber ons When intended to promote fusion of the cervical spine and occipitocervical junction When michaed to promote rast it of the sand screw (3.2 mm cortex) components of the Synthes CerviFix™ System are indicated for the following: - //vir ix Byscoin of discogenic origin with degeneration of the disc as . confirmed by patient history and radiographic studies) - spondylolisthesis . - spinal stenosis ● - fracture/dislocation . - atlantoaxial fracture with instability . - occipitocervical dislocation . - revision of previous cervical spine surgery . - tumors . When used to treat these cervical and occipitocervical conditions, these screws are limited to occipital fixation only. #### Hooks and Rods The rod and hook components are also intended to provide stabilization to promote The rod and noon components are used dislocation or trauma in the cervical/upper thoracic (C1-T3) spine. ### Rods, Clamps, Screws and Nuts Nous, Clamps, Screws and nuts are intended to promote fusion following reduction of fracture/dislocation or trauma in the upper thoracic spine (T1-T3). The use of these screws (3.5 mm, 4.0 mm cancellous and 3.5 mm, 4.2 mm cortex) is The use of these serews (5.5 mill, 1.6 in teating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine. The Synthes CerviFix™ System can also be linked to the Synthes Universal Spinal The Symnes Cer nr x - Bystem caaallel connectors from that system, and via the System using the 5.5 milli 6.5 min parares transverse process hooks, pedicle hooks, 4.2 mm screws, and the 5.0 mm/ 6.0 mm parallel connector. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) | Concurrence of CDRH-Office of Device Evaluation (ODE) | | |-------------------------------------------------------|---| | Prescription Use | X | | OR Over-the-Counter Use | | (Division Sign-Off) | Synthes Spine Co., LP | | |----------------------------------------|-----------------------------------------------------------| | Synthes CerviFix System Special 510(k) | Division of General, Restorative and Neurological Devices | | | Confidential<br>June 22, 2001 | | 510(k) Number | K011969 | |---------------|---------| |---------------|---------|