← FDA Medical Device Classifications

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

NXT · Class III — High Risk (PMA approval required, life-sustaining) · Unknown

Classification

FDA Product Code
NXT
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
Review panel
OR
Medical specialty
Unknown
Submission type
2
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N

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.

Market data

Cleared 510(k) submissions
0
Registered establishments
7

Source

Authoritative
FDA Device Classification database
Machine
JSON-LD · Markdown