Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
THINK Surgical, Inc. — Predicate Candidate Screening
23 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
57 daysmedian FDA review time
213 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261024 | TMINI Miniature Robotic System | THINK Surgical, Inc. | 2026-07-24 | 116 | 0 |
| K260010 | TMINI® Miniature Robotic System | THINK Surgical, Inc. | 2026-03-03 | 60 | 1 |
| K253661 | TMINI Miniature Robotic System | THINK Surgical, Inc. | 2025-12-22 | 32 | 0 |
| K252544 | TMINI Miniature Robotic System | THINK Surgical, Inc. | 2025-10-10 | 59 | 0 |
| K250877 | TMINI Miniature Robotic System | THINK Surgical, Inc. | 2025-06-20 | 88 | 0 |
| K243481 | TMINI Miniature Robotic System | THINK Surgical, Inc. | 2025-01-06 | 59 | 0 |
| K243285 | TMINI Miniature Robotic System | THINK Surgical, Inc. | 2024-11-15 | 28 | 0 |
| K242264 | TMINI Miniature Robotic System | THINK Surgical, Inc. | 2024-08-23 | 22 | 0 |
| K241031 | TMINI Miniature Robotic System (TMINI 1.1) | THINK Surgical, Inc. | 2024-07-12 | 88 | 0 |
| K232802 | TMINI™ Miniature Robotic System | THINK Surgical, Inc. | 2023-10-12 | 30 | 0 |
| K230202 | TMINI™ Miniature Robotic System | THINK Surgical, Inc. | 2023-04-25 | 90 | 1 |
| K203468 | TCAT TKA Instrument Tray | THINK Surgical, Inc. | 2021-12-20 | 390 | 0 |
| K210668 | TSolution One Total Knee Application | THINK Surgical, Inc. | 2021-04-01 | 27 | 0 |
| K203040 | TSolution One Total Knee Application | THINK Surgical, Inc. | 2020-11-13 | 38 | 0 |
| K201255 | TSolution® One Total Knee Application | THINK Surgical, Inc. | 2020-06-10 | 30 | 0 |
| K200632 | TCAT TKA Instrument Tray Set | THINK Surgical, Inc. | 2020-04-08 | 29 | 0 |
| K193135 | TSolution One Total Knee Application | THINK Surgical, Inc. | 2019-12-11 | 29 | 0 |
| K191369 | TSolution One Total Knee Application | THINK Surgical, Inc. | 2019-10-08 | 139 | 0 |
| K180127 | TCAT (R) THA Instrument Tray Set | THINK Surgical, Inc. | 2019-03-15 | 422 | 0 |
| K170430 | TSolution One Surgical System Model 210 | THINK Surgical, Inc. | 2017-03-06 | 21 | 0 |
| K162195 | TSolution One Cup1 Surgical System | THINK Surgical, Inc. | 2016-09-14 | 40 | 0 |
| K153647 | TSolution One w/ACG+ Surgical System | THINK Surgical, Inc. | 2016-02-16 | 57 | 0 |
| K150741 | TSolution One w/ACG surgical System | THINK Surgical, Inc. | 2015-10-22 | 213 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda