ORTHOTEC K-CAP SYSTEM

{0}------------------------------------------------ JUN 2 4 1997 Premarket Notification OrthoTec, Inc. ## (971453 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS | Submitter Name and Address: | OrthoTec, Inc.<br>1053 Koloa Street<br>Honolulu, HI 96816-510- | |-----------------------------|----------------------------------------------------------------| |-----------------------------|----------------------------------------------------------------| Contact Person: (808) 737-3224 April 9, 1997 (K831005) cap to the K-wire. Dr. Patrick Bertranou OrthoTec K-Cap System K-wire with Protective Tip fastener (21CFR 888.3040) Smooth or threaded metallic bone fixation Kirchner Wire and Steinman Pins Ethicon Fixation Pins (K833952) The device is intended to provide fixation of bone fragments or for bone reconstruction, and the cap provides protection to neighboring tissues. The K-Cap system is substantially equivalent to Kirchner Wire and Steinman Pins and to Ethicon Fixation The OrthoTec K-Cap System includes a K-wire, a protective cap (K-Cap), and applicator/handle for attachment of the Date Summary Prepared: Trade/Proprietary Name of Device: Common or Usual Name of Device: Classification Name of Device: Predicate Devices Under Which Substantial Equivalence is Being Claimed Device Description: ﻤﺴﻌ Intended Use of the Device: Comparison with Predicate Device: Pins with respect to the design, materials, and intended use. Signature: Patrick Bertranou, M.D. President OrthoTec, Inc. CONFIDENTIAL {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular pattern around a stylized emblem. The emblem consists of a triple-line design resembling an abstract caduceus, a symbol often associated with healthcare and medicine. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN 2 4 1997 Patrick Bertranou, M.D. ·President OrthoTec, Inc. 143 ½ South Swall Drive Los Angeles, California ਰੇ 000 69 Re : K971453 OrthoTec K-Cap System Regulatory Class: II Product Code: HTY Dated: April 15, 1997 Received: April 21, 1997 Dear Dr. Bertranou: 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 enclosure) 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 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 (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. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning 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. {2}------------------------------------------------ ## Page 2 - Patrick Bertranou, M.D. 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 Other qeneral 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, Mare Afclincaler, MS, PT 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 {3}------------------------------------------------ K971453/A' ## DUF of I Page_1 510(k) Number (if known):__K971453 Device Name:_ OrthoTec K-Cap System Indications For Use: The OrthoTec K-Cap System is intended to provide fixation of bone fragments or for bone reconstruction, while providing protection to neighboring tissues. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED! Concurrence of CDRH, Office of Device Evaluation (ODE) Marie Afchnoeder, ms PT fa cmw (Division Sign-On) Division of General Restorative Restorative Devices Devices 510(k) NumberK971453 Prescription Lise (Per 21 CFR 801.109) OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96) . 1