Treace Medical Concepts (TMC) Plating System
FDA 510(k) K221181 · Treace Medical Concepts, Inc.
510(k) numberK221181
Submission
- Device name
- Treace Medical Concepts (TMC) Plating System
- Applicant
- Treace Medical Concepts, Inc.
Ponte Vedra, FL, US - Received
- April 25, 2022
- Decision date
- January 5, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HRS – Plate, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HRS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261647 | Tempo Plating System; Ultra Compression Screw SystemHRS · Traditional | Pace Surgical | 09/03/2026SE |
| K261830 | FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…HRS · Traditional | Ortler Global Tibbi Gerecler Anonim Sirketi | 08/28/2026SE |
| K262537 | Versalock Sterile Plating SystemHRS · Special | GM Dos Reis Industria e Comercio Ltda. | 08/19/2026SE |
| K260277 | Mikron Trauma Bone Plate& Screw SystemHRS · Traditional | Mikron Makina San. ve Tic. Ltd. Sti. | 08/13/2026SE |
| K261511 | Xpert AnkleHRS · Traditional | Newclip Technics | 07/28/2026SE |
| K261406 | Versalock Proximal Tibial Plating SystemHRS · Traditional | GM Dos Reis Industria e Comercio Ltda. | 07/21/2026SE |
| K262032 | TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…HRS · Special | TriMed, Inc. | 07/16/2026SE |
| K261191 | Alians Elbow SHRS · Traditional | Newclip Technics | 07/08/2026SE |
| K261054 | RibPlate SystemHRS · Traditional | Stryker Leibinger GmbH & Co KG | 07/01/2026SE |
| K261351 | SALGINA 2.5mm Distal Radius SystemHRS · Traditional | Bonebridge AG | 06/26/2026SE |
More from Bonebridge AG
| 510(k) | Device | Decision |
|---|---|---|
| K260361 | Treace Medical Concepts (TMC) Screw Fixation SystemHWC · Special | 03/06/2026SE |
| K251135 | Treace Medical Concepts (TMC) Implant Fixation SystemHRS · Special | 08/21/2025SE |
| K243658 | TMC Compression Implant SystemJDR · Special | 12/26/2024SE |
| K242671 | Treace Medical Concepts (TMC) Screw Fixation SystemHWC · Special | 10/04/2024SE |
| K242415 | TMC Compression Implant SystemJDR · Special | 09/06/2024SE |
| K240173 | Treace Medical Systems (TMC) Plating SystemHRS · Special | 02/22/2024SE |
| K232387 | Treace Medical Concepts (TMC) Compression Implant SystemJDR · Special | 08/28/2023SE |
| K222645 | Treace Medical Concepts (TMC) Implant Fixation SystemJDR · Traditional | 11/21/2022SE |
| K222564 | Treace Medical Concepts (TMC) Hammertoe Fixation SystemHWC · Traditional | 11/15/2022SE |
| K220136 | Treace Medical Concepts (TMC) Plating SystemHRS · Special | 02/16/2022SE |
Questions and answers
When was Treace Medical Concepts (TMC) Plating System cleared by the FDA?
Treace Medical Concepts (TMC) Plating System (K221181) received a 510(k) decision of Substantially Equivalent on January 5, 2023, 255 days after the submission was received.
What is the product code of K221181?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.