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
K230088Substantially Equivalent

Ankle Truss System (ATS)

4Web Medical, Inc., Frisco TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K230088 is the FDA 510(k) clearance record for Ankle Truss System (ATS), a class II device, cleared for 4Web Medical, Inc. on under FDA product code SAI (Ankle Fusion Cage). FDA's definition for product code SAI reads: "Intended for use as an accessory to a tibiotalocalcaneal Intramedullary (IM) rod as part of a fusion construct for failed ankle arthrodesis or failed ankle arthroplasty. Not intended for standalone use". FDA records list 13 510(k) clearances for 4Web Medical, Inc., from to . As of , FDA records show no recalls naming K230088.

Clearance record

Decision date
Received
(434 days to decision)
Product code
SAI Ankle Fusion Cage
Regulation
21 CFR 888.3020
Device class
Class II
Review panel
Orthopedic
Applicant
4Web Medical, Inc. 2801 Network Blvd., Frisco TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SAI

Trailing 12 months

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

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