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..

2
Total
2
Cleared
205d
Avg days
2012
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer, + Additive Devices (Product Code PBI)

2 devices
1–2 of 2
Cleared Apr 28, 2022
G7® Vivacit-E® Freedom® Constrained Liner
K212512
Zimmer, Inc.
Orthopedic · 261d

About Product Code PBI - Regulatory Context

510(k) Submission Activity

2 total 510(k) submissions under product code PBI since 2012, with 2 receiving FDA clearance (average review time: 205 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.

PBI devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →