Think Surgical Inc.
Fremont, CA, US
Think Surgical Inc. appears in FDA device records in Fremont, CA. FDA records list 23 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 23 510(k) clearances for Think Surgical Inc. between 2015 and 2026. The busiest year on record is 2025, with 4. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2015 | 1 |
| 2016 | 2 |
| 2017 | 1 |
| 2019 | 3 |
| 2020 | 3 |
| 2021 | 2 |
| 2023 | 2 |
| 2024 | 3 |
| 2025 | 4 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261024 | TMINI Miniature Robotic System | OLO | Substantially Equivalent | |
| K260010 | TMINI® Miniature Robotic System | OLO | Substantially Equivalent | |
| K253661 | TMINI Miniature Robotic System | OLO | Substantially Equivalent | |
| K252544 | TMINI Miniature Robotic System | OLO | Substantially Equivalent | |
| K250877 | TMINI Miniature Robotic System | OLO | Substantially Equivalent | |
| K243481 | TMINI Miniature Robotic System | OLO | Substantially Equivalent | |
| K243285 | TMINI Miniature Robotic System | OLO | Substantially Equivalent | |
| K242264 | TMINI Miniature Robotic System | OLO | Substantially Equivalent | |
| K241031 | TMINI Miniature Robotic System (TMINI 1.1) | OLO | Substantially Equivalent | |
| K232802 | TMINI™ Miniature Robotic System | OLO | Substantially Equivalent | |
| K230202 | TMINI™ Miniature Robotic System | OLO | Substantially Equivalent | |
| K203468 | TCAT TKA Instrument Tray | KCT | Substantially Equivalent | |
| K210668 | TSolution One Total Knee Application | OLO | Substantially Equivalent | |
| K203040 | TSolution One Total Knee Application | OLO | Substantially Equivalent | |
| K201255 | TSolution® One Total Knee Application | OLO | Substantially Equivalent | |
| K200632 | TCAT TKA Instrument Tray Set | KCT | Substantially Equivalent | |
| K193135 | TSolution One Total Knee Application | OLO | Substantially Equivalent | |
| K191369 | TSolution One Total Knee Application | OLO | Substantially Equivalent | |
| K180127 | TCAT (R) THA Instrument Tray Set | KCT | Substantially Equivalent | |
| K170430 | TSolution One Surgical System Model 210 | OLO | Substantially Equivalent | |
| K162195 | TSolution One Cup1 Surgical System | OLO | Substantially Equivalent | |
| K153647 | TSolution One w/ACG+ Surgical System | OLO | Substantially Equivalent | |
| K150741 | TSolution One w/ACG surgical System | OJP | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3000719653 | 3000719653 | Think Surgical Inc. | 47201 Lakeview Blvd, Fremont, CA 94538 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2716-2026 | 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 instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon by providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components | Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array. | Class II | Open, Classified | |
| Z-1318-2024 | Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI Miniature Robotic System | There is a galling effect (cold-weld) caused by friction between the array fixation pins and the TMINI array guide holes due to insufficient clearance between the outer diameter of the fixation pins and the inner diameter of the TMINI array guide holes. As a result, the array guide has the possibility of binding to the array fixation pins during drilling. | Class II | Open, Classified | |
| Z-2605-2018 | Think Surgical Cutter, Flat, 6.2mm x 144mm. For use only with the TCAT Computer-Assisted Tool. Part Number 106428 The cutter is used to prepare the bone for the (TKA) Total Knee Arthroplasty. | There is a potential for the cutter head to detach from the cutter shaft. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain