Cleared Traditional

G7? Vivacit-E? Freedom? Constrained Liner

K212512 · Zimmer, Inc. · Orthopedic
Apr 2022
Decision
261d
Days
Class 2
Risk

About This 510(k) Submission

K212512 is an FDA 510(k) clearance for the G7? Vivacit-E? Freedom? Constrained Liner, a Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer, + Additive (Class II — Special Controls, product code PBI), submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on April 28, 2022, 261 days after receiving the submission on August 10, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3310.

Submission Details

510(k) Number K212512 FDA.gov
FDA Decision Cleared SESE
Date Received August 10, 2021
Decision Date April 28, 2022
Days to Decision 261 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code PBI — Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer, + Additive
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3310
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.