Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list THINK Surgical with 24 510(k) clearances, 4 device recalls and 2 AI-enabled devices. The most recent is a 510(k) clearance dated Oct 16, 2026: TMINI Miniature Robotic System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Oct 16, 2026 | TMINI Miniature Robotic SystemK263234 · OLO | 510(k) clearances |
| Aug 20, 2026 | Think Surgical Square Driver REF: 109126Class II · Robotic system square drive failed to meet design specifications potentially resulting in pin becoming stuck in square d | Device recalls |
| Jul 24, 2026 | TMINI Miniature Robotic SystemK261024 · OLO | 510(k) clearances |
| May 8, 2026 | TMINI Femur Tracking Array REF 109003 UDI-DI code: M9461090030 TMINI Tibia Tracking Array REF 109004 UDI-DI code: M9461090040 TMINI Class II · Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the | Device recalls |
| Mar 3, 2026 | TMINI® Miniature Robotic SystemK260010 · OLO | 510(k) clearances |
| Dec 22, 2025 | TMINI Miniature Robotic SystemK253661 · OLO | 510(k) clearances |
| Oct 10, 2025 | TMINI Miniature Robotic SystemK252544 · OLO | 510(k) clearances |
| Jun 20, 2025 | TMINI Miniature Robotic SystemK250877 · OLO | 510(k) clearances |
| Jun 20, 2025 | TMINI Miniature Robotic SystemK250877 · Neurology | AI-enabled devices |
| Jan 6, 2025 | TMINI Miniature Robotic SystemK243481 · OLO | 510(k) clearances |
| Jan 6, 2025 | TMINI Miniature Robotic SystemK243481 · Neurology | AI-enabled devices |
| Nov 15, 2024 | TMINI Miniature Robotic SystemK243285 · OLO | 510(k) clearances |
| Feb 12, 2024 | Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI Miniature Robotic SystemClass II · There is a galling effect (cold-weld) caused by friction between the array fixation pins and the TMINI array guide holes | Device recalls |
| Mar 30, 2018 | Think Surgical Cutter, Flat, ¿6.2mm x 144mm. For use only with the TCAT Computer-Assisted Tool. Part Number 106428 The cutter is used Class II · There is a potential for the cutter head to detach from the cutter shaft. | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
