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510(k) K222645

Treace Medical Concepts (TMC) Implant Fixation System by Treace Medical Concepts — Product Code JDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2022
Date Received
September 1, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Staple, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Treace Medical Concepts

  • 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)
  • K222564 — Treace Medical Concepts (TMC) Hammertoe Fixation System (November 15, 2022)
  • K220136 — Treace Medical Concepts (TMC) Plating System (February 16, 2022)

Other clearances for product code JDR

  • K250712 — Linkt Compression Staple System (May 14, 2025)
  • K243888 — Medline UNITE® REFLEX® Hybrid Nitinol Implant System (April 11, 2025)
  • K243742 — Arthrex DynaNite Nitinol Staples (January 31, 2025)
  • K243658 — TMC Compression Implant System (December 26, 2024)
  • K242415 — TMC Compression Implant System (September 6, 2024)
  • K240212 — COGNiTiON™ Staple System (February 23, 2024)
  • K232990 — A’TOMIC™ Nitinol Fixation System (January 12, 2024)
  • K230724 — arcad® 2.0 Duo & Quadro osteosynthesis compressive staples (December 4, 2023)
  • K232905 — Medline UNITE® REFLEX® Nitinol Staple Kit (October 19, 2023)
  • K232324 — StealthFix Intraosseous Fixation System (August 30, 2023)