NONLINEAR TAPER LAG SCREW

{0}------------------------------------------------ # Nonlinear Taper Lag Screw 510 (k) Summary - Company: Theken Surgical 1100 Nola Avenue Barberton, Ohio 44203 - Trade Name: Nonlinear Taper Lag Screw - Classification: Screw, Fixation, Bone. Class II. - The Nonlinear Taper Lag Screw is a cancellous lag screw with a nonlinear Description: tapered shank for optimal strength-to-diameter properties. Screws are available in a range of sizes. #### Performance Data: Non-clinical: Static and fatigue cantilever beam testing was performed. Properties of stiffness, strength, and fatigue life were characterized. ## Intended Use: The Nonlinear Taper Lag Screw is intended for the fixation of long and small bone fractures. ### Substantial Equivalence: Aesculap Titanium Alloy Bone Screws (K970549) 44 {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three lines representing its wings, head, and body. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the circumference of the circle. MAR 1 0 2000 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Lukas Eisermann Director, Regulatory Affairs Theken Surgical 1100 Nola Avenue Barberton, Ohio 44203 Re: K994382 Trade Name: Nonlinear Taper Lag Screw Regulatory Class: II Product Code: HWC Dated: December 27, 1999 Received: December 28, 1999 Dear Mr. Eisermann: 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 control provisions of the Act. The general control 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 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 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. 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. {2}------------------------------------------------ # Page 2 - Mr. Lukas Eisermann 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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, unell Vay Sy James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ K994382 5 10(k) Number Revision B, March 3, 2000 510 (k) Number (if known): Device Name: Nonlinear Taper Lag Screw 1. Indications for Use: The Nonlinear Taper Lag Screw is intended for long and small bone fracture fixation. This device is not indicated for use in the spine. Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (per 21 CFR 801.109) OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ ರ್ಥಿ (Optional Format 1:2/96) Russell Sage (Division Sign-Off) Division of General R 510(k) Number