Treace Medical Concepts, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 20
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2718-2024 | Class II | Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st | June 2, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| 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 |
| K220136 | Treace Medical Concepts (TMC) Plating System | February 16, 2022 |
| K213036 | Treace Medical Concepts (TMC) Screw Fixation System | October 21, 2021 |
| K200961 | Treace Medical Concepts (TMC) Plating System | May 8, 2020 |
| K192504 | Treace Medical Concepts (TMC) Plating System | October 30, 2019 |
| K183363 | Treace Medical Concepts (TMC) Snap-Off Screw System | June 13, 2019 |
| K183321 | Treace Medical Concepts (TMC) Plating System | January 25, 2019 |
| K173930 | PYTHON Plate Trial Instruments | March 19, 2018 |
| K172617 | Treace Medical Concepts (TMC) Compression Screw System | October 25, 2017 |
| K153531 | Treace Medical Concepts (TMC) Plating System | January 7, 2016 |
| K143717 | Treace Medical Concepts(TMC) Plating System | March 19, 2015 |