SMITH & NEPHEW FEMORAL HEADS

{0}------------------------------------------------ FEB 2 6 2003 # Summary of Safety and Effectiveness Smith & Nephew, Inc. Oxinium Femoral Heads (K024340) Page 1 of 3 ### Contact Person and Address Kim Kelly Project Manager, Clinical and Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 East Brooks Road Memphis, TN 38116 (901) 399-6566 ## Device Description The Oxinium Femoral Heads are designed for use with femoral stems and acetabular components distributed by Smith & Nephew. The Oxinium Femoral Heads are metal alloy devices processed via a proprietary oxidation process. ### Device Classification Name 21 CFR 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis:Class II 21 CFR 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis - Class II 21 CFR 888.3358 Hip joint metal/ polymer/metal semi-constrained porous coated uncemented prosthesis - Class II ## 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 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; old, remote osteomyelitis with an extended drainage-free period; nonunion; femoral neck fracture and trochanteric fractures of the proximal femur with heads involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Oxinium Femoral Heads are for single use only and can be used as part of cemented or uncemented total hip arthroplasty. #### Mechanical and Clinical Data A review of the mechanical test data indicated that the Oxinium Femoral Heads are equivalent to devices currently used clinically and are capable of withstanding expected in vivo loading without failure. {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the text "KO24340" on the first line. The second line of text says "Page 2 of 3". The text is written in a handwritten style. # Wear Claims The following marketing claims will be made for the Oxinium Femoral Heads: - Oxinium Femoral Heads show a 45% reduction in volumetric wear rates [1] 1) against conventional polyethylene when compared to equivalent sized CoCr femoral heads. Testing was performed in a multi-axial hip joint simulator for five million cvcles per individual test using a 32mm, +0 offset Oxinium Femoral Head or Smith & Nephew Universal CoCr femoral head articulating counterface; a Reflection Acetabular Liner (32mm I.D., 54mm O.D., 11mm thickness, 20° overhang), and Hyclone Modified Alpha Serum lubricant. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms or performance. - Oxinium Femoral Heads show a 61% reduction in volumetric wear rates [1] 2) against conventional polyethylene under roughened [2] conditions as compared to equivalent sized CoCr femoral heads. Testing was performed in a multi-axial hip ioint simulator for five million cycles per individual test using a 32mm, +0 offset Oxinium Femoral Head or Smith & Nephew Universal CoCr femoral head articulating counterface; a Reflection Acetabular Liner (32mm I.D., 54mm O.D., 11mm thickness, 20° overhang); and Hyclone Modified Alpha Serum lubricant. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms or performance. - 3) Oxinium Femoral Heads and CoCr Femoral Heads show no detectable wear [1] when used with crosslinked polyethylene. Testing was performed in a multi-axial hip joint simulator for five millions cycles per individual test using a 32mm, +0 offset Oxinium Femoral Head or Smith & Nephew Universal CoCr femoral head articulating counterface; a Reflection Crosslinked (10Mrad) Acetabular Liner (32mm I.D., 54-56mm O.D., 11mm thickness, Size "F", 20° overhang); and Hyclone Modified Alpha Serum lubricant. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms or performance. - 4) CoCr Femoral Heads show 15 times more volumetric wear []] against crosslinked polyethylene as compared to Oxinium Femoral Heads under roughened conditions [2]. Testing was performed in a multi-axial hip joint simulator for five millions cycles per individual test using a 32mm, +0 offset Oxinium Femoral Head or Smith & Nephew Universal CoCr femoral head articulating counterface; a Reflection Crosslinked (10Mrad) Acetabular Liner (32mm I.D., 54-56mm O.D., 11mm thickness, Size "F", 20° overhang); and Hyclone Modified Alpha Serum lubricant. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms or performance. {2}------------------------------------------------ K024340 Page 3 of 3 - 5) Oxinium Femoral Heads on crosslinked polyethylene show no detectable wear in traditional or roughened [2] conditions. Conversely, there is a measurable increase in the wear rate of crosslinked liners when a CoCr head is roughened. Testing was performed in a multi-axial hip joint simulator for five millions cycles per individual test using a 32mm, +0 offset Oxinium Femoral Head or Smith & Nephew Universal CoCr femoral head articulating counterface; a Reflection Crosslinked (10Mrad) Acetabular Liner (32mm I.D., 54-56mm O.D., 11mm thickness, Size "F", 20° overhang); and Hyclone Modified Alpha Serum lubricant. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms or performance. [1] Wear was determined by weight loss of the polyethylene liner, which was then divided by the density of the polyethylene to determine volume loss. Least squares linear regression of volume loss versus cycle count was used to determine volumetric wear-rates. [2] The roughened condition test is conducted in an effort to evaluate the effects of third body wear on the wear performance of total joint devices. The femoral heads are tumbled with abrasive media prior to testing. This method has been found to simulate the scratch patterns seen on clinically retrieved femoral heads. ## Substantial Equivalence Information The substantial equivalence of the Oxinium Femoral Heads is substantiated by its similarities in design features, overall indications, and material composition as existing femoral head components distributed by Smith & Nephew, Inc. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with three lines representing its wings and two wavy lines below representing its body. Public Health Service FEB 2 6 2003 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Kim P. Kelly Senior Regulatory & Clinical Affairs Specialist Smith & Nephew, Inc. 1450 Brooks Road Memphis, TN 38116 Re: K024340 Trade/Device Name: Oxinium Femoral Heads Regulation Number: 21 CFR 888.3350, 888.3353, 888.3358 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis, Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis, Hip joint metal/polymer/metal semiconstrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: JDI, LZO, LPH Dated: January 24, 2003 Received: January 27, 2003 Dear Ms. Kelly: 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 {4}------------------------------------------------ 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" (21 CFR 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, sincerely yours, Mark N Milkerson 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 Enclosure {5}------------------------------------------------ Page 1 of 1 # K024340 Oxinium Femoral Heads Indications Statement 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 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; old, remote osteomyelitis with an extended drainage-free period; nonunion; femoral neck fracture and trochanteric fractures of the proximal femur with heads involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. The Oxinium Femoral Heads are for single use only and can be used as part of cemented or uncemented total hip arthroplasty. for Mark N. Milkerem Division Sign-Off) Division of General. Restorative and Neurological Devices (0) 4340 510(k) Number_ Concurrence of CDRH, Office of Device Evaluation Prescription Use _____________________________________________________________________________________________________________________________________________________________ OR (Per 21 CFR 801.109) Over-The Counter Use