510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K823441Substantially Equivalent

Austin Modified Total Ossicular Replace

Treace Medical, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K823441 is the FDA 510(k) clearance record for AUSTIN MODIFIED TOTAL OSSICULAR REPLACE, a class II device, cleared for Treace Medical, Inc. on under FDA product code LBM (Porous Polyethylene Ossicular Replacement). FDA records list 80 510(k) clearances for Treace Medical, Inc., from to . As of , FDA records show no recalls naming K823441.

Clearance record

Decision date
Received
(17 days to decision)
Product code
LBM Porous Polyethylene Ossicular Replacement
Regulation
21 CFR 874.3450
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Treace Medical, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code LBM

Trailing 12 months

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

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