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U.S. Department of Health and Human Services

Product Classification

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Device prosthesis, hip, pelvifemoral resurfacing, metal/polymer, uncemented
Regulation Description Hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis.
Definition Call for pmas to be filed by 1/3/05 per 69 fr 59134 on 10/4/04 - intended to replace the articulating surfaces of the hip while preserving the femoral head and neck and indicated for osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis of the femoral head.
Physical State This generic type of device includes prostheses that consist of a femoral cap component made of a metal alloy, such as cobalt-chromium-molybdenum, or a ceramic material, that is placed over a surgically prepared femoral head, and an acetabular resurfacing polymer component.
Technical Method The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint.
Target Area hip joint
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeOCG
Premarket Review Office of Device Evaluation (ODE)
Division of Orthopedic Devices (DOD)
Joint and Fixation Devices Branch One ¿ Knees/Shoulders/Elbows/Ankles/Toes (JFDB1)
Submission Type PMA
Regulation Number 888.3410
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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