SMITH & NEPHEW MODULAR HIP

{0}------------------------------------------------ ## i - l ### Smith & Nephew, Inc. Summary of Safety and Effectiveness Smith & Nephew Modular Hip Line Additions KOS2426 pYi #### Contact Person and Address Bate of Summary: September 1, 2005 Jason Sells Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division 1450 Brooks Road Memphis, TN 38116 (901) 399-5520 Name of Device: Smith & Nephew Modular Hip Common Name: Prosthetic hip joint #### Device Description The Smith & Nephew Modular Hip consists of primary and revision stems used with porous and HA coated modular sleeves. The stems feature a 12/14 taper and are used with existing Smith & Nephew femoral heads and acetabular components. Modular hip stems and sleeves are manufactured from Ti-6Al-4V conforming to ASTM F 1472 or ASTM F 136. #### Device Classification 21 CFR 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis - Class II #### Mechanical and Clinical Data A review of the mechanical test data indicated that the Smith & Nephew Modular Hip is equivalent to devices currently used clinically and is capable of withstanding expected in vivo loading without failure. #### Indications for Use Total hip components are indicated for uncemented use in 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 head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Smith & Nephew Modular Hip components are for single use only. #### Substantial Equivalence Information The substantial equivalence of the Smith & Nephew Modular Hip is based on its similarities in indications for use, design features, operational principles, and material composition to the following predicate devices - Joint Medical Products S-ROM Total Hip System (K92111), K934412, K954935, and K961939), the Smith & Nephew Synergy Hip System (K963509, K991485, and K002996), and the Smith & Nephew Modular Hip System (K042127). The subject devices are line addition components to the Smith & Nephew Modular Hip System cleared via K042127, {1}------------------------------------------------ # Standards Data Form for Abbreviated 510(k)s 510(k) Number: K052126 : Standard Organization No: or Standard Identification No: ISO 7206-4 (1989) ASTM F67 ASTM F1472, ASTM ASTM F 136 or CDRH Internal Reference No: | Declaration of Conformity Elements: | | |-------------------------------------------------------|--------| | Any Adaptations Applied | yes no | | Any Requirements Not Applicable | yes no | | Any Deviations Applied | yes no | | Any Differences in Device Tested and Finished Product | yes no | | *Is There a Third Party or Test Lab Involved | yes no | Was there another standard used in the review of this submission? yes no If another standard was used, please fill out an additional form. * This is not the third party that reviews 510ks {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The logo also includes the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES · USA" arranged in a circular pattern around the caduceus symbol. DEC 7 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Jason Sells Regulatory Affairs Specialist Smith &Nephew, Inc Orthopaedic Division 1450 Brooks Road Memphis, Tennessee 38116 Re: K052426 Trade/Device Name: Smith & Nephew Modular Hip 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: MEH Dated: November 29, 2005 Received: November 30, 2005 Dear Mr. Sells: We have reviewed your Section 510(k) premarket notification of intent to market the device in we nave reviewed your bochen 9 re(s) personalially equivalent (for the indications ferenced above and nave determing ally marketed predicate devices marketed in interstate for use statuu in the encrobare) to 10gaily to 10gails and the Medical Device Amendments, or to commerce pror to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, devices that have been receissmed in assessment of a premarket approval application (PMA). alle Cosmetic Act (Act) that to not requent of the general controls provisions of the Act. The r ou may, mercedore, manot the Act include requirements for annual registration, listing of general controls provisions of the rice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class II (PMA), in II your device is classified (600 a0070) ins. Existing major regulations affecting your device can may be subject to such additional controls. Existing major regulation FDA Inay be subject to satin additions, Title 21, Parts 800 to 898. In addition, FDA may oc found in the Ood of reants concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that i Dri 3 issuance or our device complies with other requirements of the Act that I Dri has made a associations administered by other Federal agencies. You must of any I cochar statutes and regulations and limited to: registration and listing (21 Compry with an the Her S requirements, 01); good manufacturing practice requirements as set CIN in the quality systems (21 CFR Part 820); and if applicable, the electronic forth in the quality by bloms (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ Page 2 - Jason Sells This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to oegin marketing your and equivalence of your device to a legally premarket notification. The PDA maing of basification 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 If you desire specific advice for your act (240) 276-0120. Also, please mote the regulation entitled, and "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain Misbranding by reference to premaintential international the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, Internet andress http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, signature San Mark N. Melkerson Acting Director Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Indications for Use KOS 2476 510(k) Number (if known): Device Name: Smith & Nephew Modular Hip Indications for Use: Total hip components are indicated for uncemented use in individuals undergoing primary and rolar mp components are fire treatments or devices have failed in rehabilitating hips damaged as renout of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJ) or any of its composite diagnoses such as osteoarthritis; degenerality for it and arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; avascalar noeroant; old, remote osteomyelitis with an extended drainage-free period; nonunion, andor pril fracture and trochanteric fractures of the proximal femur with head involvement that remoral receit industans and the techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Smith & Nephew Modular Hip components are for single use only. メ Prescription Use (Part 21 CFR 801 Subpart D) AND/OR 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) 2 (Division Sign-Off) Division of General, Restorative, and Neurological Devices Page 1 of K052426