510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K031693Substantially Equivalent

Mallory/head Modular Calcar with and without Ha

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

K031693 is the FDA 510(k) clearance record for MALLORY/HEAD MODULAR CALCAR WITH AND WITHOUT HA, a class II device, cleared for Biomet, Inc. on under FDA product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented). FDA records list 872 510(k) clearances for ZIMMER GMBH, from to . As of , FDA records show 16 recalls naming K031693.

Clearance record

Decision date
Received
(65 days to decision)
Product code
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Regulation
21 CFR 888.3358
Device class
Class II
Review panel
Orthopedic
Applicant
Biomet, Inc. 56 Bell Dr., P.O. Box 587, Warsaw IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LPH

Trailing 12 months
11 clearances under product code LPH in the twelve months to October 2026, November 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code LPH, trailing twelve months
MonthClearances
November 20252
December 20251
January 20261
February 20261
March 20260
April 20260
May 20261
June 20261
July 20261
August 20262
September 20261
October 20260