ALPHATEC WIRE EXTERNAL FIXATION SYSTEM

{0}------------------------------------------------ Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 4 4 4 4 4 متر MAY 2 7 1998 Mr. Dan L. Pastrick Director of Operations Alphatec Manufacturing, Inc. 42-160 State Street Palm Desert, California 92211 K980788 Re : Alphatec Wire External Fixation System Trade Name: Requlatory Class: II Product Code: JDW Dated: March 2, 1998 Received: March 2, 1998 Dear Ms. Pastrick: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enolosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 Failure to Administration (FDA) will verify such assumptions. comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. 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. {1}------------------------------------------------ ## Page 2 - Mr. Dan L. Pastrick This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html" ..... Sincerely yours, Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## 510 (k) NUMBER (IF KNOWN): K980788 ## DEVICE NAME: Alphatec Wire External Fixation System ## INDICATIONS FOR USE: External Fixation is useful in many areas of orthopedic surgery. Following are the major categories of application: - 1) Limb salvage from traumatic injury. - 2) Fracture treatment (i.e. long bone fracture, including the tibia, femur, humerous, radius, and ulnar bones). - 3) Reconstruction of extremities with deformity and dysfunction. 4) Arthrodesis. ---------- The surgeon must carefully evaluate the purpose for external fixation in the individual patient if the treatment is to be successful. Consideration should be given to the following factors necessary for the successful application of an external fixator. Fracture osteotmy stability, soft tissue viability, adjacent function or injury, and functional demands of the patient. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IN NEEDED) Concurrence of CDRH, office of Device Evaluation (ODE) Prescription Use N (Per 21 CFR 801.109) OR Over-The-Counter-Use (Optional Format 1-2-96) cooe (Division Sign-Off) Division of General Restorative Devices 510(k) Number K980788 .