FIXION HIP SYSTEM

{0}------------------------------------------------ #### 510(K) Summary MAR 2 6 2004 # Disc-O-Tech Medical Technologies Ltd. Fixion® Hip System #### Company Name Disc-O-Tech Medical Technologies Ltd. 3 Hasadnaot St. Herzliya 46728, Israel #### Submitter's Name and Contact Person Hila Wachsler-Avrahami Disc-O-Tech Medical Technologies, Ltd. 3 Hasadnaot St. Herzliya 46728, Israel Tel: + 972-9-9511511 Fax: + 972-9-9548939 ### Date Prepared August 2003 #### Trade/Proprietary Name Fixion® Hip System #### Classification Class II {1}------------------------------------------------ #### Predicate Devices 公 Fixion® Unipolar Modular Hemi-Hip System (Fixion® MH, K014072, K030972) by Disc-O-Tech Medical Technologies Ltd. - U1 Hip System (K994078) by United Orthopedic Corporation. ﺮ - Elite® Modular Hip System (K871867) by Depuy Orthopeadics. ア - S-ROM® Total Hip System (K851422, K913231, K954935, K961939) by Depuy A Orthopeadics. - Link® MP® Hip System (K955296) by Link America Inc. 公 - Fixion® Interlocking Proximal Femoral Intramedullary Nailing System 公 (Fixion® PF, K010988, K012967, K023437) by Disc-O-Tech Medical Technologies Ltd. #### Performance Standards The following standards were referred: - ン ISO 7206-1 (Draft, 1995): Implants for Surgery - Partial and Total Hip Joint Prostheses - Part 1: Classification and Description of Dimensions. - ISO 7206-4 (Draft, 1999): Implants for Surgery Partial and Total Hip Joint 公 Prostheses - Part 4: Determination of Endurance Properties of Stemmed Femoral Components. - ISO 7206-8 (1995): Implants for Surgery Partial and Total Hip Joint A Prostheses - Part 8: Endurance Performance of Stemmed Femoral Components with Application of Torsion. - ア Guidance Document for for Femoral Stem Prostheses (Draft), ORDB/DGRD/CDRH/FDA, August 1, 1995. - 公 Guidance Document for Testing Non-Articulating, "Mechanically Locked", Modular Implant Components (Draft), ORDB/DGRD/CDRH/FDA, May 1, 1995. - ASTM F 138-2000: Standard Specification for Stainless Steel Bar and Wire ﺮ for Surgical Implants. ^{3 11}asadnao! St., Herzliya 46728, Israel; Tel: 972-9511511; Fax: 972-9-9548939; F-mail: hila@disc-o-tech.com Page 19 of 23 {2}------------------------------------------------ - - ASTM F 565-2000: Standard Practice for Care and Handling of تز Implants and Instruments. - ASTM F 1586-95: Wrought Nitrogen Strengthened 21 Chromium 10 A Nickel - 3 Manganese - 2.5. Molybdenum Stainless Steel Bar for Surgical Implants. - ISO 5832-1 (1997): Implants for Surgery Metallic Materials Part 1: ﺮ Wrought High Nitrogen Stainless Steel. - ISO 5832-9 (1995): Implants for Surgery Metallic Materials Part 9: V Wrought High Nitrogen Stainless Steel. - BS EN 12563: 1999 Non-active surgical implant Joint replacement ア implants - Specific requirements for hip joint replacement implants. #### Intended Use The Fixion® Hip System is intended for use as a hemi-hip or total hip replacement. The Fixion® Hip System is indicated as a unipolar hemi-hip replacement in cases of: - ア Femoral head and/or neck fractures or non-unions. - Aseptic necrosis of the femoral head and/or neck. ﺮ - Osteo-, rheumatoid-, and/or post-traumatic arthritis of the hip, with V minimal acetabular involvement. The Fixion® Hip System is indicated as a total hip replacement in cases of: - Painful, disabling joint disease of the hip resulting from: degenerative A arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis. - Revision of previous unsuccessful femoral head replacement, cup ﺮ arthroplasty or other procedure. - A management problems where arthrodesis or alternative Clinical reconstructive techniques are less likely to achieve satisfactory results. The Fixion® Hip Stem is intended for cemented or non-cemented use. ³ Fasadnaot St., Herzliya 46728, Jsrael, Tel: 972-9-9511511; Fax: 972-9-9548939; E-mail: hila@disc-o-tech.com Page 20 of 23 {3}------------------------------------------------ page 4 of 5 K032730 #### System Description The Fixion® Hip System is composed of an implant, inflation device (pump) and an instrumentation set. - Implant comprises femoral stem and head ball, and for total hip >> replacement - acetabular cup and liner and cancellous bone screws, as detailed below: - A stainless steel Stem, including stem body and neck, which is inserted . into the femoral medullary canal and expanded following insertion. - A Head Ball, assembled on the stem neck and articulates within the . acetabulum (in hemi-hip replacement) or acetabular cup and liner (in total hip replacement). A unipolar stainless steel head (for hemi- hip replacement), and a cobalt chromium head (for total hip replacement) are available. - A porous coated, cobalt chromium Acetabular Cup, inserted and . fixated within the acetabulum. - A UHMWPE Acetabular Cup Liner, which is seated inside the . acetabular cup. - Cobalt chromium Cancellous Bone Screws, intended to fixate the . acetabular cup to the acetabulum, in cases additional stabilization of the cup is required. - ﯩﺰ Instrumentation Set - a set of accessories to be used with the Fixion® Hip implants. - > Inflation Device (Pump) - a manual pump used to expand the Fixion® stem. #### Substantial Equivalence Hip System intended use, design, materials, technological The Fixion® characteristics and principles of operation are substantially equivalent to those of Disc-O-Tech's Fixion® Unipolar Modular Hemi-Hip System (K014072, K030972), Fixion® Interlocking PF Intramedullary Nailing System (K010988, K012967, ³ Hasadnaot St., Herzliya 46728, Israel; Tel: 972-9511511; Fax: 972-9-9548939; E-mail: hila@disc-o-tech.com; www.disc-o-tech.com Page 21 of 23 {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the text "page 5 of 5" and "k032730" written in black ink. The text "page 5 of 5" is underlined. The text appears to be handwritten. K023437), United Orthopedic Corporation' U1 Hip System (K994078 Orthopaedics' Elite® Modular Hip System (K871867) and S-ROM® Total Hip System (K851422, K913231, K954935, K961939 and others), and the Link America Inc.' Link® MP® Hip System (K955296). 3 Hasadnavt St., Herzliya 46728, Israel; Tel: 972-9-9511511; Fax: 972-9-9548939; E-mail: hila@disc-o-tech.com; www.disco-tech.com Page 22 of 23 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ ============================================================================================================================================================================== {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three stripes on its wings, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR 2 6 2004 Ms. Hila Wachsler-Avrahami Regulatory Affairs Disc-O-Tech Medical Technologies, Ltd. 3 Hasadnaot Street Herzliya 46728, Israel Re: K032730 Trade/Device Name: Fixion® Hip System Regulation Numbers: 21 CFR 888.3350; 21 CFR 888.3358; 21 CFR 888.3360 Regulation Names: Hip joint metal/polymer semi-constrained cemented prosthesis; Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis; Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis. Regulatory Class: II Product Codes: JDI, LPH, MBL, KWL, JDG, LWJ Dated: December 25, 2003 Received: December 29, 2003 Dear Ms. Wachsler-Avrahami: 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 indications for use stated in the enclosure) to legally marketed predicate 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 {6}------------------------------------------------ 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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. Mark N Milliman 'elia 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 {7}------------------------------------------------ Indication for Use Mark N. Milliner Division Sign Off: 510(K) Number (if known): K032730 Device Name: Fixion® Hip System #### Indication for Use: Division of General, Restorative, K032730 510(a) Number The Fixion® Hip System is intended for use as a hemi-hip or total hip replacement. The Fixion® Hip System is indicated as a unipolar hemi-hip replacement in cases of: - A Femoral head and/or neck fractures or non-unions. - A Aseptic necrosis of the femoral head and/or neck. - A Osteo-, rheumatoid-, and/or post-traumatic arthritis of the hip, with minimal acetabular involvement. The Fixion® Hip System is indicated as a total hip replacement in cases of: - A Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis. - Revision of previous unsuccessful femoral head replacement, cup A arthroplasty or other procedure. - A Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results. The Fixion® Hip Stem is intended for cemented or non-cemented use. Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) (Part 21 CFR 801 Subpart C) ## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) ³ Hasadnaot St., Herzliya 46728, Israel; Tel: 972-9-9511511; Fax: 972-9-9548939; E-mail: hila@disc-o-tech.com Page 16 of 23