510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K853259Substantially Equivalent for Some Indications

Mallory/head Total Hip System

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

K853259 is the FDA 510(k) clearance record for MALLORY/HEAD TOTAL HIP SYSTEM, a class II device, cleared for Biomet, Inc. on under FDA product code KMC (Prosthesis, Hip, Semi-Constrained, Composite/Metal). FDA records list 872 510(k) clearances for ZIMMER GMBH, from to . As of , FDA records show no recalls naming K853259.

Clearance record

Decision date
Received
(91 days to decision)
Product code
KMC Prosthesis, Hip, Semi-Constrained, Composite/Metal
Regulation
21 CFR 888.3340
Device class
Class II
Review panel
Orthopedic
Applicant
Biomet, Inc. P.O. Box 587, Warsaw IN
Third party review
No

Clearances, product code KMC

Trailing 12 months

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

FDA records show no clearances under product code KMC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KMC, 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