Think Surgical, Inc.
FDA Regulatory Profile
Think Surgical, Inc. appears in FDA public data with 3 recalls, 22 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2716-2026, Class II) was initiated on May 8, 2026. Its most recent 510(k) clearance was granted on March 3, 2026.
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 22
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2716-2026 | Class II | TMINI Femur Tracking Array REF 109003 UDI-DI code: M9461090030 TMINI Tibia Tracking Array REF 10 | May 8, 2026 |
| Z-1318-2024 | Class II | Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI | February 12, 2024 |
| Z-2605-2018 | Class II | Think Surgical Cutter, Flat, ¿6.2mm x 144mm. For use only with the TCAT Computer-Assisted Tool. Pa | March 30, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K260010 | TMINI® Miniature Robotic System | March 3, 2026 |
| K253661 | TMINI Miniature Robotic System | December 22, 2025 |
| K252544 | TMINI Miniature Robotic System | October 10, 2025 |
| K250877 | TMINI Miniature Robotic System | June 20, 2025 |
| K243481 | TMINI Miniature Robotic System | January 6, 2025 |
| K243285 | TMINI Miniature Robotic System | November 15, 2024 |
| K242264 | TMINI Miniature Robotic System | August 23, 2024 |
| K241031 | TMINI Miniature Robotic System (TMINI 1.1) | July 12, 2024 |
| K232802 | TMINI Miniature Robotic System | October 12, 2023 |
| K230202 | TMINI Miniature Robotic System | April 25, 2023 |
| K203468 | TCAT TKA Instrument Tray | December 20, 2021 |
| K210668 | TSolution One Total Knee Application | April 1, 2021 |
| K203040 | TSolution One Total Knee Application | November 13, 2020 |
| K201255 | TSolution® One Total Knee Application | June 10, 2020 |
| K200632 | TCAT TKA Instrument Tray Set | April 8, 2020 |
| K193135 | TSolution One Total Knee Application | December 11, 2019 |
| K191369 | TSolution One Total Knee Application | October 8, 2019 |
| K180127 | TCAT (R) THA Instrument Tray Set | March 15, 2019 |
| K170430 | TSolution One Surgical System Model 210 | March 6, 2017 |
| K162195 | TSolution One Cup1 Surgical System | September 14, 2016 |