Company · US
THINK Surgical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2015 to 2026. Name variants (Inc, Corp, punctuation) are merged.
24510(k) clearances (4 in 12 months)
4recalls (2 in 12 months)
3recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 16, 2026 | K263234 | TMINI Miniature Robotic System THINK Surgical, Inc. | OLO |
| Jul 24, 2026 | K261024 | TMINI Miniature Robotic System THINK Surgical, Inc. | OLO |
| Mar 3, 2026 | K260010 | TMINI® Miniature Robotic System THINK Surgical, Inc. | OLO |
| Dec 22, 2025 | K253661 | TMINI Miniature Robotic System THINK Surgical, Inc. | OLO |
| Oct 10, 2025 | K252544 | TMINI Miniature Robotic System THINK Surgical, Inc. | OLO |
| Jun 20, 2025 | K250877 | TMINI Miniature Robotic System THINK Surgical, Inc. | OLO |
| Jan 6, 2025 | K243481 | TMINI Miniature Robotic System THINK Surgical, Inc. | OLO |
| Nov 15, 2024 | K243285 | TMINI Miniature Robotic System THINK Surgical, Inc. | OLO |
| Aug 23, 2024 | K242264 | TMINI Miniature Robotic System THINK Surgical, Inc. | OLO |
| Jul 12, 2024 | K241031 | TMINI Miniature Robotic System (TMINI 1.1) THINK Surgical, Inc. | OLO |
| Oct 12, 2023 | K232802 | TMINI Miniature Robotic System THINK Surgical, Inc. | OLO |
| Apr 25, 2023 | K230202 | TMINI Miniature Robotic System THINK Surgical, Inc. | OLO |
| Dec 20, 2021 | K203468 | TCAT TKA Instrument Tray THINK Surgical, Inc. | KCT |
| Apr 1, 2021 | K210668 | TSolution One Total Knee Application THINK Surgical, Inc. | OLO |
| Nov 13, 2020 | K203040 | TSolution One Total Knee Application THINK Surgical, Inc. | OLO |
| Jun 10, 2020 | K201255 | TSolution® One Total Knee Application THINK Surgical, Inc. | OLO |
| Apr 8, 2020 | K200632 | TCAT TKA Instrument Tray Set THINK Surgical, Inc. | KCT |
| Dec 11, 2019 | K193135 | TSolution One Total Knee Application THINK Surgical, Inc. | OLO |
| Oct 8, 2019 | K191369 | TSolution One Total Knee Application THINK Surgical, Inc. | OLO |
| Mar 15, 2019 | K180127 | TCAT (R) THA Instrument Tray Set THINK Surgical, Inc. | KCT |
| Mar 6, 2017 | K170430 | TSolution One Surgical System Model 210 THINK Surgical, Inc. | OLO |
| Sep 14, 2016 | K162195 | TSolution One Cup1 Surgical System THINK Surgical, Inc. | OLO |
| Feb 16, 2016 | K153647 | TSolution One w/ACG+ Surgical System THINK Surgical, Inc. | OLO |
| Oct 22, 2015 | K150741 | TSolution One w/ACG surgical System THINK Surgical, Inc. | OJP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 16, 2026 | Think Surgical, Inc. Think Surgical Square Driver
REF: 109126 Open, Classified |
OLO | K261024 |
| Jul 9, 2026 | Think Surgical, Inc. TMINI Femur Tracking Array REF 109003
UDI-DI code: M9461090030
TMINI Tibia Tracking Array REF 109004
UDI-DI code: M9461090040
TMINI Miniature Robotic System is indicated as a stereotaxic instrumenta Open, Classified |
OLO | K260010 |
| Mar 20, 2024 | Think Surgical, Inc. Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI Miniature Robotic System Open, Classified |
OLO | K230202 |
| Mar 30, 2018 | Think Surgical, Inc. Think Surgical Cutter, Flat, 6.2mm x 144mm. For use only with the TCAT Computer-Assisted Tool. Part Number 106428
The cutter is used to prepare the bone for the (TKA) Total Knee Arthroplasty. Terminated |
OLO | None listed |