TAPER OXINIUM FEMORAL HEAD

{0}------------------------------------------------ Summary of Safety and Effectiveness 10/12 Taper Oxinium Femoral Heads Smith & Nephew, Inc. APR 1 1 2011 <110101 p.1/2 Date of Summary: January 11, 2011 Contact Person and Address Shereen Myers Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division 1450 East Brooks Road Memphis, Tennessee 38116 T (901) 399-6325 Name of Device: 10/12 Taper Oxinium Femoral Heads Common Name: Femoral Head Device Classification Name and Reference: 21 CFR 888.3353 Hip join metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis - Class II Device Class: Class II Panel Code: Orthopaedics/87 Predicate Devices: Total Hip Femoral Head - 12/14 Taper (K021673); and Echelon Titanium Hip System (K072817); Smith & Nephew Hip System (K022902); R3 Multi-Hole Shells and 36mm XLPE Liners (K092386); Total Hip Femoral Heads & Liners (K022958) ### Device Description Subject of this Traditional 510(k) Premarket Notification are the Smith & Nephew, Inc. 10/12 Taper Oxinium Femoral Heads. The subject devices are geometrically similar to the femoral head component in the Echelon Titanium Hip System cleared via submission K072817 and will include the addition of 32 mm and 36 mm diameter head sizes. This premarket notification seeks to add the 10/12 taper femoral head in oxidized zirconium material. Oxidized zirconium is the material of manufacture for 12/14 taper Femoral Heads cleared via submission K021673. The subject device will be offered in a size of 22 mm with offsets of -3, +0, and +3 mm; and is sizes ranging from 26 mm - 36mm, all with offsets of -5, +0, and +5 mm. #### Intended Use Total hip components are individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory ioint disease such as theumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; nonunion; femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. The subject devices are intended for single use only. #### Performance Data Performance testing of the 10/12 taper Oxinium Femoral Heads yields results at least equivalent to previously cleared devices, Total Hip Femoral head - 12/14 Taper, submission K021673; and Echelon Titanium Hip System, submission K072817. Results of testing and analysis show that the subject device performs equal to or better than previously cleared devices in regards to: {1}------------------------------------------------ K110101 p. 2/2 - . Pre-Fatigue and Post-Fatigue assembly and disassembly - . Environmental Fatigue and Corrosion - . Axial Fatigue - . Range of Motion - Device Rigidity, and . - . Wear Performance ## Substantial Equivalence Information Echelon Titanium Hip System Smith & Nephew Hip System Total Hip Femoral Heads and Liners R3 Multi-Hole Shells and 35 mm XLPE Liners The substantial equivalence of the 10/12 taper Oxinium Femoral Head is supported by its similarities in design features, overall indications, and material composition to the legally marketed devices for the total hip replacement listed in the following table: | Description | Submission<br>Number | Clearance Date | |--------------------------------------|----------------------|----------------| | Total Hip Femoral Head - 12/14 Taper | K021673 | 6/11/2002 | K072817 K022902 K092386 K022958 5/15/2008 10/2/2002 11/3/2009 10/2/2002 Table 1: Previously cleared devices to which the subject device is substantially equivalent {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The seal is black and white. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002 Smith & Nephew, Inc. % Ms. Shereen Myers Regulatory Affairs Specialist 1450 East Brooks Road Memphis, Tennessee 38116 APR 1 1 201 Re: K110101 Trade/Device Name: 10/12 Taper Oxinium Femoral Heads 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 Dated: January 12, 2011 Received: January 13, 2011 Dear Ms. Myers: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 {3}------------------------------------------------ Page 2 - Ms. Shereen Myers 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutliDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor.You/Industry/default.htm. Sincerely vours for D.A. Oct. D.R. Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Indications for Use # 510(k) Number (if known): K\\0\0\ ( pg | / | ) Device Name: 10/12 Taper Oxinium Femoral Heads Indications for Use: Total hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative ioint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; nonunion; femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. The subject devices are intended for single use only. AND/OR Prescription Use x (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C) (Please Do Not WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) for M.Melkman (Division Sign-C Division of Surgical, Orthopedic, and Restorative Device Page 1 of ____________________________________________________________________________________________________________________________________________________________________ 510(k) Number K110101