510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K953194Substantially Equivalent for Some Indications

Lactosorb Bone Pin

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

K953194 is the FDA 510(k) clearance record for LACTOSORB BONE PIN, a class II device, cleared for Biomet, Inc. on under FDA product code HTY (Pin, Fixation, Smooth). FDA records list 872 510(k) clearances for ZIMMER GMBH, from to . As of , FDA records show no recalls naming K953194.

Clearance record

Decision date
Received
(113 days to decision)
Product code
HTY Pin, Fixation, Smooth
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Biomet, Inc. Airport Industrial Park, Warsaw IN
Third party review
No

Clearances, product code HTY

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