510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K012551Substantially Equivalent

Liverpool Radial Head Replacement Device

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

K012551 is the FDA 510(k) clearance record for LIVERPOOL RADIAL HEAD REPLACEMENT DEVICE, a class II device, cleared for Biomet, Inc. on under FDA product code KWI (Prosthesis, Elbow, Hemi-, Radial, Polymer). FDA records list 872 510(k) clearances for ZIMMER GMBH, from to . As of , FDA records show no recalls naming K012551.

Clearance record

Decision date
Received
(176 days to decision)
Product code
KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
Regulation
21 CFR 888.3170
Device class
Class II
Review panel
Orthopedic
Applicant
Biomet, Inc. 56 E. Bell Dr.,, Warsaw IN
510(k) summary
Summary
Third party review
No

Clearances, product code KWI

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