Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing
The Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing (product code NXT) is a total hip resurfacing implant designed to relieve hip pain and improve hip function in patients with degenerative joint diseases such as osteoarthritis, rheumatoid arthritis, traumatic arthritis, dysplasia, or avascular necrosis, particularly for younger or more active patients who may not be suitable for traditional total hip replacement. It is classified as FDA Class 3, requiring Premarket Approval (PMA), and is reviewed by the Orthopedic panel. This device is an implant, though it does not carry a life-sustaining flag.
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Basic Information
- Product Code
- NXT
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- OR
- Submission Type
- 2
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.