510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K920446Substantially Equivalent

Total Toe System

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

K920446 is the FDA 510(k) clearance record for TOTAL TOE SYSTEM, cleared for Biomet, Inc. on under FDA product code LZJ (Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained). FDA records list 872 510(k) clearances for ZIMMER GMBH, from to . As of , FDA records show no recalls naming K920446.

Clearance record

Decision date
Received
(412 days to decision)
Product code
LZJ Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained
Device class
Unclassified
Review panel
Unknown
Applicant
Biomet, Inc. P.O. Box 587, Warsaw IN
510(k) summary
Statement
Third party review
No

Clearances, product code LZJ

Trailing 12 months

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

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