510(K) CLEARANCES 63 ▲12RECALLS POSTED 17 ▼8CLASS I 1PMA DECISIONS 48 ▼2WEEK ENDING / FDA DATA AS OF
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K984054Substantially Equivalent

Agc V2 Revision Knee System

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

K984054 is the FDA 510(k) clearance record for AGC V2 REVISION KNEE SYSTEM, a class II device, cleared for Biomet, Inc. on under FDA product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer). FDA records list 872 510(k) clearances for ZIMMER GMBH, from to . As of , FDA records show no recalls naming K984054.

Clearance record

Decision date
Received
(259 days to decision)
Product code
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Regulation
21 CFR 888.3560
Device class
Class II
Review panel
Orthopedic
Applicant
Biomet, Inc. Airport Industrial Park, Warsaw IN
510(k) summary
Summary
Third party review
No

Clearances, product code JWH

Trailing 12 months
14 clearances under product code JWH in the twelve months to November 2026, September 2026 the highest month at 6.
Show the numbers
Monthly 510(k) clearances under FDA product code JWH, trailing twelve months
MonthClearances
December 20251
January 20261
February 20260
March 20260
April 20261
May 20260
June 20261
July 20262
August 20261
September 20266
October 20261
November 20260