HOFFMANN II COMPACT PERIARTICULAR CLAMP

{0}------------------------------------------------ KA7 332) ## 510(k) Summary Trade Name: Common Name: Classification Name: Hoffmann® II Compact Periarticular Clamp External Fixation Device Smooth or Threaded Metallic Bone Fixation Fastener 888.3040 The Periarticular Clamp is an additional component of the Hoffmann® II Compact System and is intended to be used in the stabilization of open and/or unstable fractures and where soft tissue injury may preclude the use of other fracture treatments. It is manufactured from a lightweight plastic material which is radiographically transparent and allows for fracture or joint visibility on x-ray. The clamp can be used with the existing rods, couplings, clamps and fixation pins of the existing Hoffmann® II Compact System. The substantial equivalence of this device is based on similarities in intended use, design and operational principles to the Original Hoffmann® Small 4-Hole Ball Joint, Hoffmann® II Compact External Fixation System and an equivalence in material and intended use to the Agee-Wristjack (Hand Biomechanics Lab, Inc) and the Radiolucent Wrist Fixation System (Orthofix). Testing was performed to demonstrate an equivalence in performance to the Original Hoffmann® Small Four-Hole Ball Joint. The basic operational principles for the construction of external fixation frames is similar for this new clamp to those of the named external fixation devices, that is to provide external stabilization of a fracture by means of percutaneous pins connected to a frame by means of clamps, couplings and rods. The method of site preparation, relative indications and contraindications for all the external fixation devices is similar. | For information contact: | John Dichiara | |--------------------------|----------------------------------| | | Group Regulatory Affairs Manager | | | Howmedica Inc. | | | 359 Veterans Boulevard | | | Rutherford, NJ 07070 | | | (201) 507-7386 | {1}------------------------------------------------ Image /page/1/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NOV 20 1997 Mr. John Dichiara Group Regulatory Affairs Manager Howmedica Inc. Pfizer Hospital Products Group 359 Veterans Boulevard 07070-2584 Rutherford, New Jersey Re: K973321 Hoffmann® II Compact Periarticular Clamp Requlatory Class: II Product Code: KTT September 3, 1997 Dated: Received: September 4, 1997 Dear Mr. Dichiara: 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, Druq, 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸੇ 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 requlation (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 requlation 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 - Mr. John Dichiara 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 requlation (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. n Cella 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}------------------------------------------------ Indications for Use 510(k) Number (if known): Not Known Device Name: Hoffmann® II Compact Periarticular Clamp Indications for Use: The Periarticu!ar Clamp is intended to be used with the components of the Hoffmann® II Compact External Fixation System and the Half Pins or Transfixing Pins of the Hoffmann® External Fixation System. It is intended to be used in the stabilization of open and/or unstable fractures and where soft tissue injury may preclude the use of other fracture treatments_ ___________________________________________________________________________________________________________________________________________________ . . . . . . . . (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96) 510(k) Numbe