Home / 510(k) Clearances / K213036

510(k) K213036

Treace Medical Concepts (TMC) Screw Fixation System by Treace Medical Concepts, Inc. — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2021
Date Received
September 21, 2021
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Other clearances by Treace Medical Concepts, Inc.

  • K260361 — Treace Medical Concepts (TMC) Screw Fixation System (March 6, 2026)
  • K251135 — Treace Medical Concepts (TMC) Implant Fixation System (August 21, 2025)
  • K243658 — TMC Compression Implant System (December 26, 2024)
  • K242671 — Treace Medical Concepts (TMC) Screw Fixation System (October 4, 2024)
  • K242415 — TMC Compression Implant System (September 6, 2024)
  • K240173 — Treace Medical Systems (TMC) Plating System (February 22, 2024)
  • K232387 — Treace Medical Concepts (TMC) Compression Implant System (August 28, 2023)
  • K221181 — Treace Medical Concepts (TMC) Plating System (January 5, 2023)
  • K222645 — Treace Medical Concepts (TMC) Implant Fixation System (November 21, 2022)
  • K222564 — Treace Medical Concepts (TMC) Hammertoe Fixation System (November 15, 2022)

Other clearances for product code HWC

  • K260361 — Treace Medical Concepts (TMC) Screw Fixation System (March 6, 2026)
  • K252901 — Tyber Medical Trauma Screw (December 31, 2025)
  • K251555 — Ultra™ Compression Screw System (November 6, 2025)
  • K252312 — Eleganz IM Threaded Nail System (IM Threaded Nail System) (October 10, 2025)
  • K250536 — MetaFore Small Screw System (October 8, 2025)
  • K252758 — Cannulated Screw and Kirschner (K wire) System (October 2, 2025)
  • K252019 — CurvaFix Low Profile System (August 29, 2025)
  • K251382 — Phoenix Sinus Tarsi Stent System (August 27, 2025)
  • K250867 — Dunamis Screw and Suture Locking System (August 15, 2025)
  • K250251 — Eleganz Fusion Screw System (Fusion Screw System) (June 13, 2025)