MODIFICATION TO HIPSTAR FEMORAL STEM

{0}------------------------------------------------ K063822 # 510(k) Summary of Safety and Effectiveness for the HIPSTAR Femoral Stem JAN 2 5 2007 Proprietary Name: Common Name: Classification Name and Reference Regulatory Class: Device Product Code: For Information contact: Date Summary Prepared: HIPSTAR Femoral Stem Total Hip Joint Replacement Prosthesis Hip joint, metal/ceramic/polymer semiconstrained cemented or nonporous uncemented prostheses, 21 CFR §888.3353 Hip joint metal/polymer/metal semiconstrained porous-coated uncemented prosthesis 21 CFR §888.3358 Class II 87 MEH - prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calcium-phosphate 87 LZO - prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or nonporous, uncemented 87 LPH - prosthesis, hip, semi-constrained, metal/polymer, porous uncemented Tiffani Rogers Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, New Jersey 07432 Phone: (201) 831-5612 Fax: (201) 831-6038 E-Mail: Tiffani.Rogers@stryker.com January 25, 2007 {1}------------------------------------------------ ## Device Description The Hipstar Femoral Stem is a straight hip stem manufactured from titanium alloy, The Hipstar Temoral Stein is a Statight any varies a flare for rotational stability, with a TMZF - - The Fripstal Inp realersbility. The body of the stem, with the exception of the narrow unstal stem for implain cases arrit blasted for increased bone to implant interface. The subject hip stem has a 127° neck angle. ## Intended Use: The HIPSTAR hip stem is a sterile, single-use device intended for total hip arthroplasty. ### Indications - noninflammatory degenerative joint disease including osteoarthritis and avascular . necrosis; - necrosis; rheumatoid arthritis (excepting the Osteolock™ HA Acetabular Cup and Peri-● Apatite coated prostheses); - correction of functional deformity; . - correction or adures where other treatments or devices have failed; and, ● - treatment of nonunion, femoral neck and trochanteric fractures of the proximal . treatment of head involvement that are unmanageable using other techniques - intended for cementless fixation. . ### Substantial Equivalence: The subject Hipstar femoral stem is a modification to the Hipstar stem cleared in The Subject Hipstar relination of the substantial equivalence of the Hipstar hip stem is based on its similarities in intended use, design and sterilization to the previously cleared Hipstar femoral hip stem (K051223 cleared March 06, 2006). {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three figures representing people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circle around the caduceus. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Stryker Howmedica Osteonics Corporation % Ms. Tiffani Rogers Regulatory Affairs Specialist Stryker Orthopaedics 325 Corporate Drive Mahwah, New Jersey 07430 JAN 2 5 2007 Re: K063822 Trade/Device Name: HIPSTAR Femoral Stem Regulation Number: 21 CFR 888.3358, 21 CFR 888.3353 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH, LZO, MEH Dated: December 21, 2006 Received: December 22, 2007 Dear Ms. Rogers: 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 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 {3}------------------------------------------------ Page 2 - Ms. Tiffani Rogers 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 (240) 276-0120 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Sincerely yours, Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ #### Indications for Use 510(k) Number (if known): ______________________ Device Name: _________________________________________________________________________________________________________________________________________________________________ #### Indications - noninflammatory degenerative joint disease including osteoarthritis and avascular . necrosis; - rheumatoid arthritis (excepting the Osteolock™ HA Acetabular Cup and Peri-Apatite . coated prostheses); - correction of functional deformity; . - revision procedures where other treatments or devices have failed; and, ● - treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur ● with head involvement that are unmanageable using other techniques. Prescription Use _____________________________________________________________________________________________________________________________________________________________ X OR (Per 21 CFR 801.109) Over-the-Counter Use (PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Pla (Division **Division of Gene** **and Neurological**