INFINTY DISTAL FEMORAL COMPONENT

{0}------------------------------------------------ 16 1997 K973530 Contact Person: Kim Tompkins Date Prepared: September 17, 1997 ## 510(k) Summary IRLINE Trade Name: Common Name: Product Classification: Predicate Device: INFINTY® Titanium Anodized Distal Hip Component Semi-constrained hip prosthesis INFINTY® Hip System manufacture by Wright Medical Technology, Inc. and the Axis Fixation System manufactured by Sofamor Danek This 510(k) summary is being submitted in accordance with the requirements of 21 CFR §807.92. II ### Description/Intended Use The INFINTY® Titanium Anodized Distal Femoral Component is a product line addition to the INFINTY® Hip System. This modular system consists of a distal femoral component and a trochanteric module which are assembled by the surgeon at the time of surgery to yield a collared or collarless femoral hip prosthesis. The INFINTY® Hip System is designed for use with cobalt chrome or ceramic femoral heads. The INFINTY® Titanium Anodized Distal Femoral Components are available in standard and microtaper designs. Indications, design features, and functional requirements remain the same. The INFINTY® Titanium Anodized Distal Femoral Components are intended to be used in cemented or uncemented applications. The stems are manufactured from titanium alloy in conformance with ASTM F 136, and are anodized in an additional step to improve resistance to fretting corrosion and improve fatigue characteristics. #### Testing Summary Fatigue testing resulted in runout of all test specimens, demonstrating adequate fatigue strength of the INFINTY® Titanium Anodized Distal Femoral Component coupled with an INFINTY® trochanteric module. 00085 {1}------------------------------------------------ DEPARTMENT OF HEALTH & HUMA Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCT 1 6 1997 Ms. Kim Tompkins Director, Clinical and Regulatory Affairs Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002 Re : K973530 Trade Name: Infinity® Titanium Anodized Distal Hip Component Regulatory Class: II Product Codes: LPH, JDI, and LZO Dated: September 17, 1997 Received: September 18, 1997 Dear Ms. Tompkins: 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 Requlations, Title 21, Parts 800 to 895. ಗಿ 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 In addition, FDA may publish further announcements action. 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 requlations. {2}------------------------------------------------ Page 2 - Ms. Kim Tompkins 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, permils 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.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ #### Indications For Use of the Device C. Page 1 of 1 | 510(k) Number (if known): | K973530 | |---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name: | INFINTY® Titanium Anodized Distal Femoral<br>Components | | Indications for Use: | | | | in total hip arthroplasty for reduction or relief of pain and/or<br>improved hip function in skeletally mature patients with the<br>following conditions: | | 1. | Non-inflammatory degenerative joint disease such as<br>osteoarthritis, avascular necrosis, ankylosis, protrusio<br>acetabuli, and painful hip dysplasia; | | 2. | Inflammatory degenerative joint disease such as<br>rheumatoid arthritis; | | 3. | Correction of function deformity: | | 4. | Revision procedures where other treatments or devices<br>have failed; and | | 5. | Treatment of nonunion, femoral neck, and trochanteric<br>fractures of the proximal femur with head involvement that<br>are unmanageable using other techniques. | | | (Please do not write below this line-continue on another page if needed) | | | * * * * * * * * * | | | Concurrence of CDRH, Office of Device Evaluation (ODE) | | | <div> <p>(Division Sign-Off)</p> <p>Division of General Restorative Devices</p> </div> | | 510(k) Number | K973530 | Prescription Use_X_ Or (Per 21 CFR 801.109) Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96) # 0000009