510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K010212Substantially Equivalent

Offset Tibial Tray

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

K010212 is the FDA 510(k) clearance record for OFFSET TIBIAL TRAY, a class II device, cleared for Biomet, Inc. on under FDA product code MBV (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer). FDA records list 872 510(k) clearances for ZIMMER GMBH, from to . As of , FDA records show 3 recalls naming K010212.

Clearance record

Decision date
Received
(22 days to decision)
Product code
MBV Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer
Regulation
21 CFR 888.3560
Device class
Class II
Review panel
Orthopedic
Applicant
Biomet, Inc. Airport Industrial Park, Warsaw IN
510(k) summary
Summary
Third party review
No

Clearances, product code MBV

Trailing 12 months

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

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