THINK Surgical, Inc.

Code	Device name	Class	Specialty	Clearances	Most recent
OLO	Orthopedic Stereotaxic Instrument	Class II	Neurology	14	2026-07-24
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	Class II	General Hospital	2	2021-12-20

Date	Severity	Status	Recall #	Product	Code	Reason
2024-02-12	Class II	Ongoing	Z-1318-2024	Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI Miniature Robotic S…	—	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 t…

Date	K-number	Device	Code	Class	Specialty
2026-07-24	K261024	TMINI Miniature Robotic System	OLO	Class II	Neurology
2026-03-03	K260010	TMINI® Miniature Robotic System	OLO	Class II	Neurology
2025-12-22	K253661	TMINI Miniature Robotic System	OLO	Class II	Neurology
2025-10-10	K252544	TMINI Miniature Robotic System	OLO	Class II	Neurology
2025-06-20	K250877	TMINI Miniature Robotic System	OLO	Class II	Neurology
2025-01-06	K243481	TMINI Miniature Robotic System	OLO	Class II	Neurology
2024-11-15	K243285	TMINI Miniature Robotic System	OLO	Class II	Neurology
2024-08-23	K242264	TMINI Miniature Robotic System	OLO	Class II	Neurology
2024-07-12	K241031	TMINI Miniature Robotic System (TMINI 1.1)	OLO	Class II	Neurology
2023-10-12	K232802	TMINI Miniature Robotic System	OLO	Class II	Neurology
2023-04-25	K230202	TMINI Miniature Robotic System	OLO	Class II	Neurology
2021-12-20	K203468	TCAT TKA Instrument Tray	KCT	Class II	General Hospital
2021-04-01	K210668	TSolution One Total Knee Application	OLO	Class II	Neurology
2020-11-13	K203040	TSolution One Total Knee Application	OLO	Class II	Neurology
2020-06-10	K201255	TSolution® One Total Knee Application	OLO	Class II	Neurology
2020-04-08	K200632	TCAT TKA Instrument Tray Set	KCT	Class II	General Hospital

Clearance cadence by quarter