510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K014164Substantially Equivalent

Great Toe Implant System

Harmos Orthopaedics, Inc., Cantonville MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K014164 is the FDA 510(k) clearance record for GREAT TOE IMPLANT SYSTEM, a class II device, cleared for Harmos Orthopaedics, Inc. on under FDA product code KWD (Prosthesis, Toe, Hemi-, Phalangeal). FDA records list one 510(k) clearance for Harmos Orthopaedics, Inc. As of , FDA records show no recalls naming K014164.

Clearance record

Decision date
Received
(83 days to decision)
Product code
KWD Prosthesis, Toe, Hemi-, Phalangeal
Regulation
21 CFR 888.3730
Device class
Class II
Review panel
Orthopedic
Applicant
Harmos Orthopaedics, Inc. 1002 Frederick Rd., Cantonville MD
510(k) summary
Summary
Third party review
No

Clearances, product code KWD

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