Treace Medical Concepts (TMC) Compression Implant System
FDA 510(k) K232387 · Treace Medical Concepts
510(k) numberK232387
Submission
- Device name
- Treace Medical Concepts (TMC) Compression Implant System
- Applicant
- Treace Medical Concepts
Ponte Vedra, FL, US - Received
- August 9, 2023
- Decision date
- August 28, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDR – Staple, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code JDR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262451 | Arthrex DynaNite StaplesJDR · Traditional | Arthrex, Inc. | 09/01/2026SE |
| K261121 | Megalodon Dynamic Compression SystemJDR · Traditional | Paragon 28, Inc. | 08/06/2026SE |
| K250712 | Linkt Compression Staple SystemJDR · Traditional | Trax Surgical | 05/14/2025SE |
| K243888 | Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemJDR · Traditional | Medline Industries, LP | 04/11/2025SE |
| K243742 | Arthrex DynaNite Nitinol StaplesJDR · Traditional | Arthrex, Inc. | 01/31/2025SE |
| K243658 | TMC Compression Implant SystemJDR · Special | Treace Medical Concepts | 12/26/2024SE |
| K242415 | TMC Compression Implant SystemJDR · Special | Treace Medical Concepts | 09/06/2024SE |
| K240212 | COGNiTiON Staple SystemJDR · Special | Ortho Solutions UK , Ltd. | 02/23/2024SE |
| K232990 | ATOMIC Nitinol Fixation SystemJDR · Traditional | Rmr Ortho, LLC | 01/12/2024SE |
| K230724 | arcad® 2.0 Duo & Quadro osteosynthesis compressive staplesJDR · Traditional | Novastep | 12/04/2023SE |
More from Novastep
| 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 |
| 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) Compression Implant System cleared by the FDA?
Treace Medical Concepts (TMC) Compression Implant System (K232387) received a 510(k) decision of Substantially Equivalent on August 28, 2023, 19 days after the submission was received.
What is the product code of K232387?
The FDA product code is JDR – Staple, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.