Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive
PBI · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.3310
Classification
FDA Product Code
PBI
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 888.3310
Review panel
OR
Medical specialty
Orthopedic
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N
Definition
For use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained acetabular components have been considered.