510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K942263Substantially Equivalent for Some Indications

Miller/galante Precoat Unicompartmental Knee System

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

K942263 is the FDA 510(k) clearance record for MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE SYSTEM, a class II device, cleared for Zimmer, Inc. on under FDA product code HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer). FDA records list 872 510(k) clearances for Zimmer, Inc., from to . As of , FDA records show one recall naming K942263.

Clearance record

Decision date
Received
(428 days to decision)
Product code
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Regulation
21 CFR 888.3520
Device class
Class II
Review panel
Orthopedic
Applicant
Zimmer, Inc. P.O. Box 708, Warsaw IN
Third party review
No

Clearances, product code HSX

Trailing 12 months
2 clearances under product code HSX in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HSX, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260