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Think Surgical Inc.

US

Last updated September 17, 2026

Information

Country
US
Address
47201 Lakeview Blvd, Fremont, CA, 94538
Website
—
LinkedIn
—
Facebook
—
Email
—
Phone
—
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
3000719653
DUNS Number
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Catalogue (99)

Page 2 of 2
DeviceModel / ReferenceRegistriesClassStatus
Tsolution One Surgical System 107665
FDA UDI
Class IIActive
Array Guide 109101
FDA UDI
Class IIActive
Tsolution One Surgical System 103426
FDA UDI
Class IIActive
TMINI™ Guide Block Kit for U2™ Knee Total Knee System 109422
FDA UDI
Class IIActive
Tsolution One Surgical System 105715
FDA UDI
Class IIActive
Tsolution One Surgical System 103725
FDA UDI
Class IIActive
Tsolution One Surgical System 107719
FDA UDI
Class IIActive
TMINI™ Robot 109343
FDA UDI
Class IIActive
TMINI® Guide Block Kit for Zimmer Biomet: Anterior Referencing Persona® Knee 109993
FDA UDI
Class IIActive
Tsolution One Surgical System 103205
FDA UDI
Class IIActive
TPLAN® Planning Station 109000
FDA UDI
Class IIActive
Tsolution One Surgical System 107642
FDA UDI
Class IIActive
Tsolution One Surgical System 103384
FDA UDI
Class IIActive
Tsolution One Surgical System 102613
FDA UDI
Class IIActive
Tsolution One Surgical System 105717
FDA UDI
Class IIActive
Tsolution One Surgical System 103279
FDA UDI
Class IIActive
Tsolution One Surgical System 102794
FDA UDI
Class IIActive
Tsolution One Surgical System 106298-03
FDA UDI
Class IIActive
TMINI® Guide Block Kit for Total Joint Orthopedics Klassic® Knee System (10ea) 109900-B
FDA UDI
Class IIActive
Tsolution One Surgical System 107644
FDA UDI
Class IIActive
Pin Puller 109565
FDA UDI
Class IIActive
Tsolution One Surgical System 105734
FDA UDI
Class IIActive
TMINI® Guide Block Kit for b-ONE MOBIO® Total Knee System 109974
FDA UDI
Class IIActive
Tightening Tool 109060
FDA UDI
Class IIActive
TMINI™ Guide Block Kit for Enovis™ EMPOWR Knee System®(10ea) 109900-A
FDA UDI
Class IIActive
Femur Tracking Array 109003
FDA UDI
Class IIActive
TMINI® Guide Block Kit for Ortho Development® Balanced Knee® (10ea) 109900-C
FDA UDI
Class IIActive
TMINI Miniature Robotic System K243285
FDA 510(k)
Class IIActive
TMINI™ Miniature Robotic System K232802
FDA 510(k)
Class IIActive
TMINI Miniature Robotic System K242264
FDA 510(k)
Class IIActive
TMINI Miniature Robotic System K253661
FDA 510(k)
Class IIActive
TMINI™ Miniature Robotic System K230202
FDA 510(k)
Class IIActive
TSolution One w/ACG+ Surgical System K153647
FDA 510(k)
Class IIActive
TCAT (R) THA Instrument Tray Set K180127
FDA 510(k)
Class IIActive
TSolution One Total Knee Application K210668
FDA 510(k)
Class IIActive
TCAT TKA Instrument Tray K203468
FDA 510(k)
Class IIActive
TSolution One Cup1 Surgical System K162195
FDA 510(k)
Class IIActive
TCAT TKA Instrument Tray Set K200632
FDA 510(k)
Class IIActive
TMINI® Miniature Robotic System K260010
FDA 510(k)
Class IIActive
TMINI Miniature Robotic System K250877
FDA 510(k)
Class IIActive
TMINI Miniature Robotic System (TMINI 1.1) K241031
FDA 510(k)
Class IIActive
TSolution One Total Knee Application K191369
FDA 510(k)
Class IIActive
TSolution One Total Knee Application K193135
FDA 510(k)
Class IIActive
TSolution® One Total Knee Application K201255
FDA 510(k)
Class IIActive
TSolution One w/ACG surgical System K150741
FDA 510(k)
Class IIActive
TMINI Miniature Robotic System K252544
FDA 510(k)
Class IIActive
TSolution One Surgical System Model 210 K170430
FDA 510(k)
Class IIActive
TMINI Miniature Robotic System K243481
FDA 510(k)
Class IIActive
TSolution One Total Knee Application K203040
FDA 510(k)
Class IIActive

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Authorised Representatives

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Importers

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Notified Bodies

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Authorities

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FDA Recalls (2)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

DateRecall No.ClassStatusReason
Feb 12, 2024Z-1318-2024—open, classified

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.

Mar 30, 2018Z-2605-2018—terminated

There is a potential for the cutter head to detach from the cutter shaft.