510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K212512Substantially Equivalent

G7® Vivacit-E® Freedom® Constrained Liner

Zimmer GmbH, Warsaw IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K212512 is the FDA 510(k) clearance record for G7® Vivacit-E® Freedom® Constrained Liner, a class II device, cleared for Zimmer, Inc. on under FDA product code PBI (Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive). FDA's definition for product code PBI reads: "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...". FDA records list 872 510(k) clearances for Zimmer, Inc., from to . As of , FDA records show no recalls naming K212512.

Clearance record

Decision date
Received
(261 days to decision)
Product code
PBI Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive
Regulation
21 CFR 888.3310
Device class
Class II
Review panel
Orthopedic
Applicant
Zimmer, Inc. 1800 W. Center St., Warsaw IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PBI

Trailing 12 months

FDA records hold no clearances under product code PBI in the trailing twelve months.

FDA records show no clearances under product code PBI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PBI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260