TMINI Miniature Robotic System
THINK Surgical, Inc.The TMINI Miniature Robotic System is a robotic surgical tool designed to assist orthopedic surgeons in accurately placing knee implant components during total knee replacement surgery. It uses preoperative CT scans to generate 3D models for surgical planning and utilizes robotic guidance during surgery to ensure precise bone preparation and implant placement, improving surgical accuracy and patient outcomes.
Intended Use
Intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
Technology
Consists of a 3D graphical Preoperative Planning Workstation (TPLAN Planning Station) that uses CT scans to create 3D surface models for case templating and registration. Includes THINK Case Manager (web-based surgical plan review) and an Optical Tracking Navigation Console controlling a robotically controlled handheld tool assisting in bone preparation and implant placement. The robot is optically tracked relative to markers on the femur and tibia and articulates in two degrees of freedom to position bone pins and mechanical guides accurately during surgery.
Performance
Performance testing included full system run-through, cutting accuracy (pin and block placement), cadaver lab validation, gap balance accuracy, user needs validation, usability, and software testing. All tests passed with no new questions of safety or effectiveness. Biocompatibility tests for patient-contacting materials were conducted on the predicate device with none required due to software-only modifications. Risk assessment in accordance with ISO 14971:2019 found no new hazards or risks caused by the device updates.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/24/2025
2 months - 2
FDA Approval
6/20/2025
Other devices from THINK Surgical, Inc.
- TMINI Miniature Robotic System2025 • 510K
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