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U.S. Department of Health and Human Services

Product Classification

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Device prosthesis, hip, semi-constrained, metal/metal, resurfacing
Definition Prosthesis, hip, semi-constrained, metal/metal, resurfacing device relieves hip pain and improves hip function by replacing the parts of the hip that have been severely damaged by degenerative joint diseases. This device is indicated for patients with degenerative joint diseases including osteoarthritis, rheumatoid arthritis, traumatic arthritis, dysplasia, or avascular necrosis and for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional total hip replacement due to an increased possibility of requiring future hip joint revision.
Physical State The femoral resurfacing component and acetabular components are made of metal. These surfaces rub against each other (the bearing couple) and are made from highly-polished metal. This type of bearing couple is called a metal-on-metal bearing couple.
Technical Method Prosthesis, hip, semi-constrained, metal/metal, resurfacing device has two parts: a socket in the shape of a shallow cup (acetabular component), and a cap in the form of a ball head (femoral resurfacing component). The cup replaces the damaged surface of the hip socket (acetabulum). The cap covers or resurfaces the ball-shaped bone at the top of the thigh (femoral head), and the cap has a small stem that is inserted into the top of the thighbone. The cap moves within the cup.
Target Area The device is to replace the hip joint.
Review Panel Orthopedic
Product CodeNXT
Premarket Review Office of Orthopedic Devices (OHT6)
Joint Arthroplasty Devices (DHT6A)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? Yes
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible