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510(k) K230088

Ankle Truss System (ATS) by 4Web Medical, Inc. — Product Code SAI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2024
Date Received
January 12, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ankle Fusion Cage
Device Class
Class II
Regulation Number
888.3020
Review Panel
OR
Submission Type

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.

Other clearances by 4Web Medical, Inc.

  • K252834 — Sacroiliac Joint Truss System (SJTS) (January 28, 2026)
  • K253200 — Cervical Spine Truss System - Stand Alone (CSTS-SA) (December 11, 2025)
  • K251117 — Cervical Spine Truss System (CSTS) (April 25, 2025)
  • K240388 — Osteotomy Truss System (OTS) (November 1, 2024)
  • K233966 — Anterior Spine Truss System-Stand Alone (ASTS-SA) (April 22, 2024)
  • K231739 — Cervical Spine Truss System (CSTS) (September 25, 2023)
  • K223362 — Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device (February 2, 2023)
  • K221266 — Cervical Spine Truss System (CSTS) Interbody Fusion Device (January 5, 2023)
  • K221283 — Hammertoe Truss System (HTS) (September 6, 2022)
  • K220463 — Osteotomy Truss System (OTS) (May 18, 2022)

Other clearances for product code SAI

  • K242356 — TIDAL Fusion Cage System (March 24, 2025)