THINK Surgical, Inc.
Medical device manufacturer in Fremont, CA.
23510(k) clearances
0PMA approvals
3recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K261024 | TMINI Miniature Robotic SystemOLO · Traditional | 07/24/2026SE |
| K260010 | TMINI® Miniature Robotic SystemOLO · Traditional | 03/03/2026SE |
| K253661 | TMINI Miniature Robotic SystemOLO · Special | 12/22/2025SE |
| K252544 | TMINI Miniature Robotic SystemOLO · Traditional | 10/10/2025SE |
| K250877 | TMINI Miniature Robotic SystemOLO · Traditional | 06/20/2025SE |
| K243481 | TMINI Miniature Robotic SystemOLO · Traditional | 01/06/2025SE |
| K243285 | TMINI Miniature Robotic SystemOLO · Special | 11/15/2024SE |
| K242264 | TMINI Miniature Robotic SystemOLO · Special | 08/23/2024SE |
| K241031 | TMINI Miniature Robotic System (TMINI 1.1)OLO · Traditional | 07/12/2024SE |
| K232802 | TMINI Miniature Robotic SystemOLO · Special | 10/12/2023SE |
| K230202 | TMINI Miniature Robotic SystemOLO · Traditional | 04/25/2023SE |
| K203468 | TCAT TKA Instrument TrayKCT · Traditional | 12/20/2021SE |
| K210668 | TSolution One Total Knee ApplicationOLO · Special | 04/01/2021SE |
| K203040 | TSolution One Total Knee ApplicationOLO · Special | 11/13/2020SE |
| K201255 | TSolution® One Total Knee ApplicationOLO · Special | 06/10/2020SE |
| K200632 | TCAT TKA Instrument Tray SetKCT · Special | 04/08/2020SE |
| K193135 | TSolution One Total Knee ApplicationOLO · Special | 12/11/2019SE |
| K191369 | TSolution One Total Knee ApplicationOLO · Traditional | 10/08/2019SE |
| K180127 | TCAT (R) THA Instrument Tray SetKCT · Traditional | 03/15/2019SE |
| K170430 | TSolution One Surgical System Model 210OLO · Special | 03/06/2017SE |
| K162195 | TSolution One Cup1 Surgical SystemOLO · Special | 09/14/2016SE |
| K153647 | TSolution One w/ACG+ Surgical SystemOLO · Traditional | 02/16/2016SE |
| K150741 | TSolution One w/ACG surgical SystemOJP · Traditional | 10/22/2015SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2716-2026 Class II | TMINI Femur Tracking Array REF 109003 UDI-DI code: M9461090030 TMINI Tibia Tracking…Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential… | 05/08/2026Open, Classified |
| Z-1318-2024 Class II | Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used…There is a galling effect (cold-weld) caused by friction between the array fixation pins and the TMINI array… | 02/12/2024Open, Classified |
| Z-2605-2018 Class II | Think Surgical Cutter, Flat, 6.2mm x 144mm. For use only with the TCAT Computer-Assisted…There is a potential for the cutter head to detach from the cutter shaft. | 03/30/2018Terminated |