THINK Surgical, Inc.
THINK Surgical, Inc. holds FDA 510(k) medical device clearances, first cleared 2015, most recent 2026, with 3 FDA device recalls on record.
Top product codes for THINK Surgical, Inc.
FDA recalls by THINK Surgical, Inc.
- 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
- Z-1318-2024 — Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI Miniature Robotic System
- 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.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by THINK Surgical, Inc.
- K261024 — TMINI Miniature Robotic System
- K260010 — TMINI® Miniature Robotic System
- K253661 — TMINI Miniature Robotic System
- K252544 — TMINI Miniature Robotic System
- K250877 — TMINI Miniature Robotic System
- K243481 — TMINI Miniature Robotic System
- K243285 — TMINI Miniature Robotic System
- K242264 — TMINI Miniature Robotic System
- K241031 — TMINI Miniature Robotic System (TMINI 1.1)
- K232802 — TMINI Miniature Robotic System
- K230202 — TMINI Miniature Robotic System
- K203468 — TCAT TKA Instrument Tray
- K210668 — TSolution One Total Knee Application
- K203040 — TSolution One Total Knee Application
- K201255 — TSolution® One Total Knee Application
- K200632 — TCAT TKA Instrument Tray Set
- K193135 — TSolution One Total Knee Application
- K191369 — TSolution One Total Knee Application
- K180127 — TCAT (R) THA Instrument Tray Set
- K170430 — TSolution One Surgical System Model 210
- K162195 — TSolution One Cup1 Surgical System
- K153647 — TSolution One w/ACG+ Surgical System
- K150741 — TSolution One w/ACG surgical System
Data sourced from openFDA. This site is unofficial and independent of the FDA.