PBI · Class II · 21 CFR 888.3310

FDA Product Code PBI: Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer, + Additive

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.

Leading manufacturers include Zimmer, Inc..

1
Total
1
Cleared
261d
Avg days
2022
Since

List of Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer, + Additive devices cleared through 510(k)

1 devices
1–1 of 1
Cleared Apr 28, 2022
G7® Vivacit-E® Freedom® Constrained Liner
K212512
Zimmer, Inc.
Orthopedic · 261d

How to use this database

This page lists all FDA 510(k) submissions for Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer, + Additive devices (product code PBI). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Orthopedic FDA review panel. Browse all Orthopedic devices →