Data / Medical devices / United States / Think Surgical Inc.
Think Surgical Inc.: FDA-registered device maker in Fremont, CA, United States, 9 510(k) clearances
Think Surgical Inc. is registered with the FDA (registration 3000719653) in Fremont, CA, United States. It lists 1 device type. The FDA files 9 510(k) clearances under its listings, the newest dated October 16, 2026. 4 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3000719653
- Address
- 47201 Lakeview Blvd, Fremont, CA, United States, 94538
- Owner or operator
- Think Surgical Inc. (10028805)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- May 25, 2023
- Registered through
- 2026
- Brand names listed
- TMINI Miniature Robotic System, TMINI Miniature Robotic System (TMINI 1.1), TMINI Miniature Robotic System (TPLAN/TCM)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Orthopedic Stereotaxic Instrument | OLO | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 16, 2026 | K263234 | TMINI Miniature Robotic System | OLO | Substantially Equivalent | THINK Surgical, Inc. | accessdata.fda.gov |
| March 3, 2026 | K260010 | TMINI® Miniature Robotic System | OLO | Substantially Equivalent | THINK Surgical, Inc. | accessdata.fda.gov |
| December 22, 2025 | K253661 | TMINI Miniature Robotic System | OLO | Substantially Equivalent | THINK Surgical, Inc. | accessdata.fda.gov |
| January 6, 2025 | K243481 | TMINI Miniature Robotic System | OLO | Substantially Equivalent | THINK Surgical, Inc. | accessdata.fda.gov |
| November 15, 2024 | K243285 | TMINI Miniature Robotic System | OLO | Substantially Equivalent | THINK Surgical, Inc. | accessdata.fda.gov |
| August 23, 2024 | K242264 | TMINI Miniature Robotic System | OLO | Substantially Equivalent | THINK Surgical, Inc. | accessdata.fda.gov |
| July 12, 2024 | K241031 | TMINI Miniature Robotic System (TMINI 1.1) | OLO | Substantially Equivalent | THINK Surgical, Inc. | accessdata.fda.gov |
| October 12, 2023 | K232802 | TMINI Miniature Robotic System | OLO | Substantially Equivalent | THINK Surgical, Inc. | accessdata.fda.gov |
| April 25, 2023 | K230202 | TMINI Miniature Robotic System | OLO | Substantially Equivalent | THINK Surgical, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 20, 2026 | 99870 | Class II | Ongoing | Think Surgical Square Driver REF: 109126 | Robotic system square drive failed to meet design specifications potentially resulting in pin becoming stuck in square driver or the pin wobbling during drilling. | accessdata.fda.gov |
| May 8, 2026 | 99219 | Class II | Ongoing | 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 | Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array. | accessdata.fda.gov |
| February 12, 2024 | 94086 | Class II | Ongoing | 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. | accessdata.fda.gov |
| March 30, 2018 | 80091 | Class II | Terminated | 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. | accessdata.fda.gov |
Compare with other makers
Updated October 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.