Treace Medical Concepts (TMC) Screw Fixation System
FDA 510(k) K260361 · Treace Medical Concepts, Inc.
510(k) numberK260361
Submission
- Device name
- Treace Medical Concepts (TMC) Screw Fixation System
- Applicant
- Treace Medical Concepts, Inc.
Ponte Vedra, FL, US - Received
- February 4, 2026
- Decision date
- March 6, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HWC – Screw, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HWC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261057 | ActivaScrew Cannulated COMHWC · Traditional | Bioretec, Ltd. | 09/04/2026SE |
| K260106 | OsteoCoil GT Active Compression SystemHWC · Traditional | Flower Orthopedics Corporation DBA Conventus… | 08/24/2026SE |
| K262344 | Large Compression ScrewsHWC · Special | TriMed, Inc. | 08/12/2026SE |
| K253858 | GFS - Sterile Screws and Top HatHWC · Special | T.A.G. Medical Products Corporation, Ltd. | 08/05/2026SE |
| K262075 | Lapidus Screw KitHWC · Special | Relja Innovations, LLC | 07/22/2026SE |
| K260809 | Arthrex Sterile VAL and VAL KreuLock Compression Screw SystemHWC · Traditional | Arthrex, Inc. | 06/25/2026SE |
| K253108 | VEOFIX Snap Off ScrewHWC · Traditional | Steps Ortho | 06/05/2026SE |
| K261154 | CoLink® & CoLag® Non-Sterile ScrewsHWC · Special | In2Bones USA, LLC | 05/30/2026SE |
| K261241 | TriMed Compression ScrewsHWC · Special | TriMed, Inc. | 05/14/2026SE |
| K254215 | Arthrex Beaming SystemHWC · Traditional | Arthrex, Inc. | 05/08/2026SE |
More from Arthrex, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K221181 | Treace Medical Concepts (TMC) Plating SystemHRS · Traditional | 01/05/2023SE |
| 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) Screw Fixation System cleared by the FDA?
Treace Medical Concepts (TMC) Screw Fixation System (K260361) received a 510(k) decision of Substantially Equivalent on March 6, 2026, 30 days after the submission was received.
What is the product code of K260361?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.