SULZER ORTHOPEDICS CONVERGE ACETABULAR SYSTEM

{0}------------------------------------------------ ## OCT 1 8 2001 K012961 p 1/2 ### 510(k) SUMMARY 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 Converge Acetabular System. | Manufacturer: | Sulzer Orthopedics Inc.<br>9900 Spectrum Drive<br>Austin, Texas 78717<br>(512) 432-9900 | |-------------------------|-------------------------------------------------------------------------------------------------------| | Date: | September 27, 2001 | | Contact Person: | Mitchell A. Dhority<br>Director, Regulatory & Clinical Affairs | | Classification Name: | Hip Joint Metal/Polymer/Metal Semi-constrained Porous-coated<br>Uncemented Prosthesis, 21CFR 888.3358 | | Common/Usual Name: | Acetabular Shell Components | | Trade/Proprietary Name: | Sulzer Orthopedics Converge Acetabular System | #### PRODUCT DESCRIPTION The Converge Acetabular System consists of the following shell components: - I. Hemispherical The Converge Hemispherical Shell is a porous coated, Ti-6A1-4V (ASTM F136) shell. The outer surface of the shell has CSTi porous coating (commercially pure titanium) to provide for biological fixation. The shell is available in various sizes ranging from 39mm to 65mm (in 2mm increments). The shell features 2 screwhole plugs that are sintered in place. The screwhole plugs can be removed intraoperatively before or after implantation if the surgeon opts to enhance fixation of the shell with bone screws. When left in place (no supplemental screws used), the screwhole plugs limit material ingress and egress (e.g., tissue, debris particles, cement, etc.). - II. Rim-Flare The Converge Rim Flare Shell is a Ti-6AI-4V metallic acetabular shell coated with CSTi porous coating. It is designed with an offset outer radius in the rim region which permits the loads to be transmitted to the periphery of the outer surface. An initial press-fit of the component is achieved by the offset radius in this region. Additionally, the outer design of the shell incorporates three pegs which are press-fit into the cancellous bone of the reamed acetabulum to minimize the potential for tilting or rotation of the device. The shell is available in various sizes ranging from 39mm to 71mm (in 2mm increments). {1}------------------------------------------------ K012961 P2/2 #### III. Revision The Converge Revision Shell is a Ti-6Al-4V metallic acetabular shell coated with CSTi porous coating. The Revision shell has up to nine screwholes which allow for screw placement into the illum, ischium and pubis. Those screwholes that are not utilized may be plugged after implantation to limit passage of tissue, debris particles, cement, etc. The shell is available in various sizes ranging from 43mm (in 2mm increments). All three Converge shells feature a central dome hole which allows for interface with the impactor/alignment instrument as well as for visualization of the acetabulum to ensure complete seating of the device. The dome hole may be plugged using a threaded cover to restrict unwanted material migration through the hole. All three of the Converge shell components will use existing Inter-Op instrumentation and will mate with currently marketed Inter-Op Acetabular Inserts (oxygenless packaged polyethylene, Durasul, or Metasul). ### SPECIFIC DIAGNOSTIC INDICATIONS Components of the Converge 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 arthroplasty where there is sufficient bone stock to support the . implant. #### SUBSTANTIAL EQUIVALENCE Substantial equivalence is based on comparison to the Inter-Op Acetabular System. The fundamental scientific technologies previously incorporated into the Inter-Op Acetabular System have not changed in the Converge Acetabular System. The main difference is relative to changes being made to the manufacturing process which should provide additional assurance of cleanliness. These manufacturing process changes have also necessitated some minor changes in design for the Converge, all of which were assessed relative to the Inter-Op and found to be acceptable. Based on conformance with the design control requirements as specified in 21 CFR 820.30 and similarities in design, materials, sterilization, intended use and indications for use, we believe that the Converge Acetabular System is substantially equivalent to the previously cleared Inter-Op Acetabular System. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with stylized wings. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## OCT 1 8 2001 Mr. Mitchell A. Dhority Director, Regulatory & Clinical Affairs Sulzer Orthopedics Inc. 9900 Spectrum Drive Austin, Texas 78717 Re: K012961 Trade/Device Name: Converge Acetabular System Regulation Number: 21 CFR §888.3350 and §888.3358 Regulation Name: hip joint metal/polymer semi-constrained cemented prosthesis; hip joint metal/poly/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: JDI and LPH Dated: August 31, 2001 Received: September 4, 2001 Dear Mr. Dhority: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the referenced doove and no the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of Amendinents, or to act 1100 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 approvisions 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 (1 Mr), it may of such of Federal Regulations, Title 21, Parts 800 to 898. In your device can or foundsh further announcements concerning your device in the Federal Register. {3}------------------------------------------------ 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 meall that ITDA has made a deceminations administered by other Federal agencies. of the Act of ally I ederal states and reguirements, including, but not limited to: registration 1 ou must comply with an all also rise ling (21 CFR Part 801); good manufacturing practice allo listing (21 CFR Part 807), labelity systems (QS) regulation (21 CFR Part 820); and if requirents as set forth in the quality byovensions (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) I mis letter will anow you to objak finding of substantial equivalence of your device to a premarket notification. - The PDF 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 If you desire specific acritor for your avitro diagnostic devices), please contact the Office of additionally 21 OFF F 8 4-4659. Additionally, for questions on the promotion and Compliance at (301) 59 to rease contact the Office of Compliance at (301) 594-4639. advertising or your arragulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under noutheation \[21 OF ICT affor the Division of Small Manufacturers, International and the Act may be obtained 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, Sincerely yours, Mark N. Milliman 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 {4}------------------------------------------------ 510(k) Number (if known): KO12961 Device Name: Converge Acetabular System # Indications for Use: Components of the Converge 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 . patient Conditions of nominations of wisgint disease (IJD), e.g., rheumatoid arthritis. - necrosis, osteourinitio, and minus surgery where pain, deformity, or dysfunction persists. . - those patients with ranse provises where there is sufficient bone stock to support the . implant. ### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use X