WHITESIDE BIOMECHANICS TITANIUM LOW-PROFILE CABLE, MODEL BIO-1-1013

{0}------------------------------------------------ # FEB 1 4 2000 K 993903/A' PAGE 1 OF 2 #### Section 4: 510(k) Summary | Company Name/Address: | Whiteside Biomechanics, Inc.<br>12634 Olive Blvd.<br>St. Louis, MO 63141<br>P: 314-996-8540<br>F: 314-996-8543 | |-------------------------------|----------------------------------------------------------------------------------------------------------------| | Establishment Registration #: | 1932213 | | Correspondent: | Debra Meyer | | Device Name: | Whiteside Biomechanics Low-Profile<br>Titanium Cable System | | Proprietary Name: | Whiteside Biomechanics, Inc. Low-Profile<br>Titanium Cable System | | Common Name: | Surgical Cable | | Classification Name: | Bone Fixation Cerclage | | Classification Panel: | General & Plastic Surgery | | Substantial Equivalence To: | Whiteside Biomechanics Low-Profile Cable<br>System (K951844) | #### Device Description: This implant consists of a 0.058" diameter cable, 23" in length, 20" length cable and 3" length lead and a cylindrical crimp with a transverse "through hole". The crimp, cable and lead cable are supplied as a single assembled unit. All three are preassembled in the manufacturing process. The cable is manufactured according to the material specifications for ASTM F136-96 in a 7 x 7 x 0.00064 wire construct. The crimp is also manufactured from ASTM F136-96. A cable passer may be used to pass the free end of the cable around the bone. The free end is then passed through the transverse hole of the crimp in such manner as to have the free end emerge from the center of the crimp. A cable tensioner may be used to achieve a desired cable tension a which time the surgeon uses a crimper/cutter to crimp near the middle of the "through hole" and cuts the free end from the crimp. {1}------------------------------------------------ ## Device Intended Use: a) General orthopedic uses. - b) Trochanteric reattachment. - c) Fixation of long bone fractures-elbow, shoulder, ankle, patella. - d) Trauma fixation of shoulder, ankle and patella . - e) General spinal uses. - f) Spinal wiring. ### Technological Comparison: The Whiteside Biomechanics, Inc. Titanium Low-Profile Cable System is substantially equivalent to the predicate device. There are no different technological characteristics between the Whiteside Biomechanics Low-Profile Cable System and the Whiteside Biomechanics, Inc. Titanium Low-Profile Cable System. {2}------------------------------------------------ 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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human figures, one behind the other, facing to the right. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB 1 4 2000 Ms. Debra R. Meyer Whiteside Biomechanics, Inc. 12634 Olive Boulevard St. Louis, Missouri 63141 Re: K993903 Trade Name: Whiteside Biomechanics Low-Profile Titanium Cable System Regulatory Class: II Product Code: JDQ Dated: November 12, 1999 Received: November 16, 1999 Dear Ms. Meyer: 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 (OS) 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. {3}------------------------------------------------ Page 2 - Ms. Debra R. Meyer 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, Nil RP Ogden James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ #### Indications for Use Section 10: ### Device Intended Use: - a) General orthopedic uses. - b) Trochanteric reattachment. - c) Fixation of long bone fractures-elbow, shoulder, ankle, patella. - d) Trauma fixation of shoulder, ankle and patella . - e) General spinal uses. - f) Spinal wiring. NRO for IZD (Division Sign-Off) Division of General Restorative Devices 510(k) Number K993903 X Prescription Use . (Per 21 CFR 801.109)