PBI

Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive

Product code

PBI

Device name

Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive

Device class

Class 2

21 CFR

21 CFR 888.3310

Medical specialty

Orthopedic

Marketing pathway

510(K)

Flag

Implant

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).