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Tmini Miniature Robotic System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K253661

by Think Surgical, Inc.

Identifiers

510(k) Number
K253661 FDA 510(k)
FDA Product Code
OLO FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.4560 FDA 510(k)
Regulation Number
882.4560 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Tmini Miniature Robotic System is a robotic system designed to enable accurate and precise implant placement. It is a handheld, wireless system that integrates into the operating room with overhead active tracking, allowing for unrestricted patient access. The system uses CT-based 3D surgical planning and enables intraoperative adjustments to fine-tune implant positioning.

The Tmini Miniature Robotic System is supplied as a miniature robotic system with a workflow to enable precise implant placement. It has an FDA 510K authorization and is classified under product code OLO. The system is designed for use in neurology and has a special clearance type. It is available with a specific k number, K253661.

Frequently asked questions

What is the TMINI Miniature Robotic System used for?

The TMINI Miniature Robotic System is designed for precise implant placement in neurology, utilizing CT-based 3D surgical planning and allowing for intraoperative adjustments.

How is the TMINI Miniature Robotic System supplied?

The TMINI Miniature Robotic System is supplied as a miniature robotic system with a workflow to enable precise implant placement, and it is available with a specific k number, K253661.

Is the TMINI Miniature Robotic System cleared for use?

The TMINI Miniature Robotic System has an FDA 510K authorization, indicating that it is substantially equivalent to a predicate device and has been cleared for use.

What type of clearance does the TMINI Miniature Robotic System have?

The TMINI Miniature Robotic System has a special clearance type, and it is classified under product code OLO.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: TMINI - THINK Surgical, TMINI® Miniature Robotic System - Zimmer Biomet, Home - THINK Surgical

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Think Surgical, Inc.

Sources (1)

  • FDA 510(k) K253661 24 fields · synced Sep 21, 2026