ACCOLADE RPS HIP STEM

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image is a black and white abstract design. The left side of the image is solid black, while the right side is white. There is a transition area between the black and white, where the black gradually fades into white with a speckled effect. SEP 2 7 2005 Image /page/0/Picture/2 description: The image contains the names of three companies: Stryker, Howmedica, and Osteonics. The text is black and the background is white. The names are stacked vertically, with Stryker at the top, Howmedica in the middle, and Osteonics at the bottom. The font is bold and easy to read. 325 Corporate Drive Mahwah, NJ USA 07430 # 510(k) Summary of Safety and Effectiveness for the Accolade® RPS Femoral Stem **Proprietary Name:** Common Name: Classification Name and Reference Regulatory Class: Device Product Code: For Information contact: Accolade® RPS Femoral Stem Total Hip Joint Replacement Prosthesis Hip joint, metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prostheses, 21 CFR §888.3353 Class II 87 MEH - prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calciumphosphate, 87 LZO - prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented Tiffani Rogers Regulatory Affairs Specialist Stryker Orthopaedics 325 Corporate Drive Mahwah, New Jersey 07430 Phone: (201) 831-5412 Fax: (201) 831-6038 E-Mail: Tiffani.Rogers@stryker.com Date Summary Prepared: September 13, 2005 ## Device Description The existing Accolade® TMZF® HA Hip System features femoral stems in neutral, press-fit versions consisting of a variety of lengths and two neck angles, 132° and 127°. The subject Accolade® RPS Hip Stem is a modification to the existing hip stems. It features a reduction in the area of Commercially Pure Titanium (CP-Ti) plasma spray and PureFixTM HA coatings on Image /page/0/Picture/22 description: The image shows a black and white abstract pattern. The pattern is concentrated in the lower left corner and extends upwards. The pattern is made up of small, irregular shapes and lines. \$\frac{1}{2}\$ {1}------------------------------------------------ I body of the stem. The subject hip stem, like the predicate hip stems, is ured using TMZF® alloy. ### ended Use: The subject hip stem is a single-use, sterile device intended for use in total hip replacement. It is The subject imp stem is a = = = intended for the reconstruction of the head and neck of the femoral joint. This hip stem is intended for the reconstruction of the proximal femur or revision total hip arthroplasty. This intended for primary device is intended for use with any currently available Howmedica Osteonics acetabular device is miches. component and V40™ femoral heads that can be mated with a TMZF® 5° 40' BG trunnion. #### Indications: - Cementless primary hip surgery in cases of non-inflammatory degenerative joint disease . Cententess primary inf varseular necrosis, rheumatoid arthritis, and correction of functional deformity. - Treatment of nonunion, and femoral neck and trochanteric fractures of the proximal femur . with head involvement that are unmanageable using other techniques. - Revision procedures where other treatments or devices have failed. . #### Substantial Equivalence: The determination of the substantial equivalence of the Accolade® RPS hip stem is based on its similarities in intended use, design and sterilization to the Accolade® TMZF® femoral stem (K994366, cleared March 16, 2000). Predicate device information is located in Appendix E. 4 {2}------------------------------------------------ Image /page/2/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a simple, bold font and is horizontally aligned. The background is plain and white, which makes the text stand out. Image /page/2/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The seal is encircled by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement. SEP 27 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Tiffani D. Rogers Regulatory Affairs Specialist Stryker Howmedica Osteonics Corporation 325 Corporate Drive Mahwah, New Jersey 07430 Re: K052542 Trade/Device Name: Accolade® RPS Hip Stem Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: LZO, MEH Dated: September 14, 2005 Received: September 15, 2005 Dear Ms. Rogers: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becternined 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 encreate) to regions the Medical Device Amendments, or to commerce prior to May 20, 1976, in ecordance with the provisions of the Federal Food, Drug, devices mat have been reculise in assess as as a proval of a premarket approval application (PMA). and Cosmetic Act (71ct) that to not request in the general controls provisions of the Act. The 1 ou may, merelore, mains of the Act include requirements for annual registration, listing of general controls provisions of tractice, 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 If your device is classified (see aberty) als. Existing major regulations affecting your device can may be subject to saterial 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 rease oe avrised has i termination that your device complies with other requirements of the Act that I DA has made a and regulations administered by other Federal agencies. You must of uny I odelul states and we wents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set OFF 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. {3}------------------------------------------------ Page 2- Ms. Tiffani D. Rogers This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter witi anow you to begin mantening of substantial equivalence of your device to a legally premarket nothleanon. The PDA maing of cacommand of 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 Jour do 110-76-0120. Also, please note the regulation entitled, p Colliact the Office of Complance at (1) + + = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = Misoranting by release to premainters in the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, Internet address http://www.fda.gov/cdrl/industry/support/index.html. Sincerely yours, Mark A. Millerson Mark N. Melkerson Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ | 510(k) Number (if known): | | |---------------------------|------------------------| | Device Name: | Accolade® RPS Hip Stem | Indications for Use Indications - Cementless primary hip surgery in cases of non-inflammatory - Cementless primary hip surgery in cases of non-inflammatory degenerative joint disease . including ostcoarthritis, avascular necrosis, rheumatoid arthritis, and correction of functional deformity. - Treatment of nonunion, and femoral neck and trochanteric fractures of the proximal femur . with head involvement that are unmanageable using other techniques. - Revision procedures where other treatments or devices have failed. . Prescription Use X OR Over-the-Counter Use (Per 21 CFR 801.109) (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Mark D. Milliken (Division Sign-Off) Division of General, Restorative, and Neurological Devices 510(k) Number