510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K240475Substantially Equivalent

Hintermann Series H2 Total Ankle System

Vilex LLC, Mcminnville TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K240475 is the FDA 510(k) clearance record for Hintermann Series H2 Total Ankle System, a class II device, cleared for Vilex, LLC on under FDA product code HSN (Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer). FDA records list 27 510(k) clearances for Vilex, LLC, from to . As of , FDA records show no recalls naming K240475.

Clearance record

Decision date
Received
(286 days to decision)
Product code
HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Regulation
21 CFR 888.3110
Device class
Class II
Review panel
Orthopedic
Applicant
Vilex, LLC 111 Moffitt St., Mcminnville TN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HSN

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