TMINI Miniature Robotic System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K243481 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 handheld, wireless robotic device designed for precise implant placement in orthopedic procedures. Classified under product code OLO, it integrates advanced robotic technology to assist surgeons in achieving accurate intraoperative adjustments, supported by CT-based 3D surgical planning. Its compact, miniature form factor enables seamless integration into the operating room environment without restricting patient access.
This system is supplied as a reusable medical device and is intended for use in sterile surgical settings. It features overhead active tracking for real-time positioning guidance and is regulated under FDA 510(k) clearance (K243481) as substantially equivalent to existing devices. The device is engineered for orthopedic applications, adhering to regulatory standards for robotic-assisted surgical tools. Storage and handling follow manufacturer guidelines to maintain functionality and sterility.
Frequently asked questions
What types of orthopedic procedures is the TMINI Miniature Robotic System designed to assist with specifically?
The TMINI Miniature Robotic System is designed to assist surgeons with precise implant placement in orthopedic procedures. Its advanced robotic technology, combined with CT-based 3D surgical planning, enables accurate intraoperative adjustments, making it particularly useful for procedures requiring high precision in positioning implants.
Is the TMINI system reusable or single-use, and how should it be handled to maintain sterility?
The TMINI Miniature Robotic System is a reusable medical device, meaning it is intended for repeated use in sterile surgical settings. To maintain sterility and functionality, it must be handled according to the manufacturer’s guidelines, which likely include proper cleaning, sterilization, and storage protocols before and after each use.
How does the TMINI system ensure accurate implant positioning during surgery?
The TMINI system uses overhead active tracking for real-time positioning guidance, allowing surgeons to make precise intraoperative adjustments. This feature, combined with CT-based 3D surgical planning, helps ensure accurate and reliable implant placement during orthopedic procedures.
What regulatory pathway was followed for the TMINI Miniature Robotic System, and what does that mean for its use?
The TMINI Miniature Robotic System was cleared through the FDA’s 510(k) process (K243481) under a Traditional review, with a decision of Substantially Equivalent (SESE) to existing devices. This means it has been evaluated and determined to be as safe and effective as legally marketed predicate devices, allowing it to be used in clinical settings as intended for orthopedic implant procedures.
How does the compact design of the TMINI system benefit surgeons during surgery?
The TMINI’s miniature and handheld design allows for seamless integration into the operating room without obstructing patient access or requiring extensive workspace adjustments. This compact form factor enhances maneuverability and flexibility, enabling surgeons to work efficiently while maintaining precision in implant placement.
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, Home - THINK Surgical, TMINI® Miniature Robotic System - Zimmer Biomet
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K243481 | Class II | Active |
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Manufacturer
- Manufacturer
- Think Surgical, Inc.
Sources (1)
- FDA 510(k) K243481 24 fields · synced Sep 20, 2026