Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive
Medical specialty
Orthopedic
Device class
2
Regulation number
888.3310
Review panel
OR
Implant
Y
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
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.