510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NXTClass III

Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

Unknown
FDA source (opens on fda.gov)

NXT is the FDA product code for Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing, a class III device type. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and 6 recalls.

Classification record

Product code
NXT
Device name
Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing
FDA 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.
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
6

Companies listing this code with FDA

Companies whose registered establishments list this code