ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTS

{0}------------------------------------------------ #### 510(k) SUMMARY DEC 1 3 2001 K013935 In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this is to serve as a Summary of Safety and Effectiveness for the Sulzer Orthopedics Ltd. Allofit Acetabular System 32mm Alpha Durasul Inserts. | Manufacturer: | Sulzer Orthopedics Ltd. | |-------------------------|-------------------------------------------------------------------------------------------------------------------------| | | Grabenstrasse 25<br>CH-6341 Baar, Switzerland | | US Distributor: | Sulzer Orthopedics Inc.<br>9900 Spectrum Drive<br>Austin, Texas 78717<br>(512) 432-9900 | | Date: | November 27, 2001 | | Contact Person: | Mitchell A. Dhority<br>Director, Regulatory & Clinical Affairs | | Classification Name: | 21 CFR Part 888.3353 - Hip joint metal/ceramic/polymer semi-<br>constrained cemented or nonporous uncemented prosthesis | | Common/Usual Name: | Acetabular Insert Components | | Trade/Proprietary Name: | Allofit Acetabular System 32mm Alpha Durasul Inserts | ### PRODUCT DESCRIPTION This Special 510(k) submission seeks to obtain clearance for addition of the Allofit 32mm Alpha Durasul Inserts to the existing, previously cleared (K003578) Allofit 28mm Alpha Durasul Insert product line. The only difference from the existing product is the internal diameter of the insert (32mm vs. 28mm). There are also no changes to the other previously cleared components of the system which are used in conjunction with the inserts (e.g, acetabular shells, dome hole covers, screw hole covers, instrumentation). The Allofit 32mm Alpha Durasul inserts incorporate the same general design features as the existing, previously cleared Allofit 28mm Alpha Durasul insert components and Allofit 32mm Alpha inserts (standard Sulene polyethylene). The inserts are snapped into the respective Allofit titanium shell intraoperatively. A peripheral locking mechanism holds the insert within the shell. A peg shaped eminence at the apex of the insert slips into the dome hole of the shell and provides further stability of the insert within the shell. Upon impaction into the short spikes in the dome of the metallic shell minimally penetrate the polyethylene insert, providing additional resistance to rotation. Both a standard and hooded insert configuration will continue to be offered. The Allofit 32mm Alpha Durasul inserts will also use the same materials as the previously cleared devices (ISO 5834-1/2). The Durasul material is identical to that which was previously {1}------------------------------------------------ characterized and cleared for use in the Allofit 28mm Alpha Durasul Inserts. ## SPECIFIC DIAGNOSTIC INDICATIONS There have been no changes in the diagnostic indications from the previously cleared components as a result of this line addition. Components of the Allofit Acetabular System are intended for use in total hip arthroplasty for treatment of the following: - patient conditions of noninflammatory degenerative joint disease (NIDJD); e.g., avascular . necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis. - those patients with failed previous surgery where pain, deformity, or dysfunction persists. . - revision of a previously failed hip arthroplasty. . #### SUBSTANTIAL EQUIVALENCE Substantial equivalence is based on comparison to the previously cleared Allofit 28mm Alpha Durasul Inserts. The fundamental scientific technologies incorporated in this previously cleared design have not changed in this product line addition. The only difference in the existing Allofit Alpha Durasul Insert components and this line addition is the internal diameter (32mm vs. 28mm). Based on conformance with the design control requirements as specified in 21 CFR 820.30 and similarities in design, materials, sterilization, packaging, instrumentation, intended use and indications for use, we believe that the Allofit 32mm Alpha Durasul Inserts are substantially equivalent to the previously cleared Allofit 28mm Alpha Durasul Inserts. {2}------------------------------------------------ Image /page/2/Picture/2 description: The image shows the address of the Food and Drug Administration. The address is 9200 Corporate Boulevard, Rockville MD 20850. The text is black and the background is white. DEC 1 3 2001 Mr. Mitchell A. Dhority Director, Regulatory & Clinical Affairs Sulzer Orthopedics Incorporated 9900 Spectrum Drive Austin. Texas 78717 Re: K013935 Trade Name: Allofit Acetabular System/32mm Alpha Inserts Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: LZO Dated: November 27, 2001 Received: November 28, 2001 Dear Mr. Dhority: We have reviewed your Section 510(k) premarket 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration {3}------------------------------------------------ ## Page 2 - Mr. Dhority Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes 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 forth 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. This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, 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. Mal. N. Millan 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 {4}------------------------------------------------ . . #### K013935 510(k) Number (if known): Device Name: Allofit Acetabular System - Alpha 32mm Durasul Inserts # Indications for Use: Components of the Allofit Acetabular System are intended for use in total hip arthroplasty for treatment of the following: - patient conditions of noninflammatory degenerative joint disease (NIDJD); e.g., avascular . necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., theumatoid arthritis. - those patients with failed previous surgery where pain, deformity, or dysfunction persists. . - revision of a previously failed hip arthroplasty. . # (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) પ્ર Prescription Use _ OR Over-The-Counter Use Mark n-Mllever (Optional Format 1-2-96) 1 Pestorative vices 510(k) Number__