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Think Surgical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
22
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1318-2024Class IIAssembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINIFebruary 12, 2024
Z-2605-2018Class IIThink Surgical Cutter, Flat, ¿6.2mm x 144mm. For use only with the TCAT Computer-Assisted Tool. PaMarch 30, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K260010TMINI® Miniature Robotic SystemMarch 3, 2026
K253661TMINI Miniature Robotic SystemDecember 22, 2025
K252544TMINI Miniature Robotic SystemOctober 10, 2025
K250877TMINI Miniature Robotic SystemJune 20, 2025
K243481TMINI Miniature Robotic SystemJanuary 6, 2025
K243285TMINI Miniature Robotic SystemNovember 15, 2024
K242264TMINI Miniature Robotic SystemAugust 23, 2024
K241031TMINI Miniature Robotic System (TMINI 1.1)July 12, 2024
K232802TMINI™ Miniature Robotic SystemOctober 12, 2023
K230202TMINI™ Miniature Robotic SystemApril 25, 2023
K203468TCAT TKA Instrument TrayDecember 20, 2021
K210668TSolution One Total Knee ApplicationApril 1, 2021
K203040TSolution One Total Knee ApplicationNovember 13, 2020
K201255TSolution® One Total Knee ApplicationJune 10, 2020
K200632TCAT TKA Instrument Tray SetApril 8, 2020
K193135TSolution One Total Knee ApplicationDecember 11, 2019
K191369TSolution One Total Knee ApplicationOctober 8, 2019
K180127TCAT (R) THA Instrument Tray SetMarch 15, 2019
K170430TSolution One Surgical System Model 210March 6, 2017
K162195TSolution One Cup1 Surgical SystemSeptember 14, 2016