510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K922211Substantially Equivalent for Some Indications

Osteomed Great Toe System

Osteomed, Glendale CA / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K922211 is the FDA 510(k) clearance record for OSTEOMED GREAT TOE SYSTEM, cleared for Osteomed Corp. on under FDA product code LZJ (Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained). FDA records list 73 510(k) clearances for Osteomed Corp., from to . As of , FDA records show no recalls naming K922211.

Clearance record

Decision date
Received
(546 days to decision)
Product code
LZJ Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained
Device class
Unclassified
Review panel
Unknown
Applicant
Osteomed Corp. 6062 San Fernando Rd., Glendale CA
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