TMINI Miniature Robotic System
THINK Surgical, Inc.The TMINI Miniature Robotic System is a robotic-assisted surgical device designed to help surgeons accurately plan and execute total knee replacement surgeries. It uses preoperative CT scans to create 3D bone models, allowing precise implant positioning through software planning and robotic guidance. The system enhances surgical accuracy and efficiency by using AI-enhanced image segmentation, intraoperative tracking, and spatial boundary definition during surgery.
Intended Use
The TMINI System is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
Technology
The system comprises a 3D graphical preoperative planning workstation (TPLAN Planning Station) that uses CT imaging for 3D bone model creation and implant templating. It features an Optical Tracking Navigation Console (TNav) for intraoperative tracking and a handheld robotically controlled tool that assists in bone preparation and implant placement. The updated system uses a pre-trained machine learning model to improve segmentation of CT data, enhanced DICOM import, improved implant display and a web-based application (THINK Case Manager) for surgical plan review and approval.
Performance
Performance testing included full system run through, cutting accuracy tests (pin and block placement, cadaver lab validation, system gap balance accuracy), user needs validation, usability and software testing, all of which passed. Risk assessment found no new clinical hazards or new safety/effectiveness questions. Biocompatibility tests passed with no new materials introduced.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/8/2024
1 month - 2
FDA Approval
1/6/2025
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