PBI — Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive Class II

FDA Device Classification

Classification Details

Product Code
PBI
Device Class
Class II
Regulation Number
888.3310
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K212512zimmerG7® Vivacit-E® Freedom® Constrained LinerApril 28, 2022
K121874biomet manufacturingG7 ACETABULAR SYSTEMNovember 23, 2012