DURASUL BIPOLAR

{0}------------------------------------------------ KD40947 ## AUG 2 7 2004 #### 510(k) SUMMARY | SPONSOR NAME: | Zimmer<br>9900 Spectrum Drive<br>Austin, TX 78717 | |-----------------|--------------------------------------------------------------------------------------------------------------------------------| | 510(k) CONTACT: | Audrey Swearingen<br>Phone: (512) 432-9255<br>Audrey.Swearingen@Zimmer.com | | TRADE NAME: | Durasul® Bipolar | | COMMON NAME: | Hemi-Hip | | CLASSIFICATION: | Hip Joint Femoral (Hemi-Hip) Metal/Polymer Cemented or<br>Uncemented Prosthesis (87 KWY) are Class II per 21 CFR<br>§888.3390. | ### PREDICATE DEVICES: - Centerpulse Orthopedics, Inc. Bipolar (K873815) and . - Exactech's AcuMatch L-Series Bipolar (K013211). . ### DEVICE DESCRIPTION: The Durasul Bipolar consists of a polyethylene insert/liner and an outer CoCr shell. In vivo, the CoCr shell articulates directly with well-preserved articular cartilage while the Durasul insert articulates directly with a 22 or 26mm femoral head. The Durasul Bipolar components are available in a variety of sizes to allow the surgeon to replicate the natural anatomy of the hip joint as closely as possible when performing a hip hemi-arthroplasty. #### INTENDED USE: The Durasul Bipolar is intended for non-cemented use in a hip hemi-arthroplasty in which it assumes the function of the natural femoral head in conjunction with a prosthetic femoral head component. Specific diagnostic indications for use of a bipolar include displaced femoral neck fractures, avascular necrosis of the femoral head, and non-union of femoral neck fractures. #### BASIS OF SUBSTANTIAL EQUIVALENCE: Performance tests, design comparisons, and functional analyses conducted on the Durasul Bipolar demonstrate that this device is substantially equivalent to the predicate devices. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles an abstract caduceus or a stylized representation of human figures. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 27 2004 Ms. Audrey Swearingen Manager, Regulatory Affairs Zimmer Inc. 9900 Spectrum Drive Austin, Texas 78717 Re: K040947 Trade/Device Name: Durasul® Bipolar Regulation Number: 21 CFR 888.3390 Regulation Name: Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis Regulatory Class: II Product Code: KWY Dated: August 6, 2004 Received: August 9, 2004 Dear Ms. Swearingen: We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to commerce pror to that 20, 1977, in accordance with the provisions of the Federal Food, Drug, devices that have been rouire approval of a premarket approval application (PMA). and Costiere Act (110.) that to nevice, subject to the general controls provisions of the Act. The I ou may, therefore, mans. of the Act include requirements for annual registration, listing of general controls provisions of ractice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it n your device is elassinod (tional controls. Existing major regulations affecting your device can may oc subject to back acceral Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oc devilod that I Dr o last is to the complies with other requirements of the Act that I Dr Has Intacted and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Orth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {2}------------------------------------------------ Page 2 - Ms. Audrey Swearingen This letter will allow you to begin marketing your device as described in your Section 510(k) I ins letter will anow you to ogin mailing of substantial equivalence of your device to a legally premarket notheation: "The PDF mining of dassification 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), please If you desire specific advice for your ac (301) 594-4659. Also, please note the regulation entitled, Colliation of Gollippiante in (Set notification" (21CFR Part 807.97). You may obtain Misoranung Uy Telefone to premainter to premainter the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Mark A. Melleson Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known): K040947 Device Name: Durasul® Bipolar Indications for Use: The Durasul Bipolar is intended for non-cemented use in a hip hemi-arthroplasty in which it assumes the function of the natural femoral head in conjunction with a prosthetic femoral head component. Specific diagnostic indications for use of a bipolar include displaced femoral neck fractures, avascular necrosis of the femoral head, and non-union of femoral neck fractures. X Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) #### Concurrence of CDRH, Office of Device Evaluation for ODE) Mark A Mulkeren Division of General, Restorative, and Neurological Devices Page 1 of 1 K040947 510(k) Number_________________________________________________________________________________________________________________________________________________________________