Dynamis Robotic Surgical System
LEM Surgical AGThe Dynamis Robotic Surgical System is a robotic platform designed to assist surgeons in precisely locating anatomical structures and guiding surgical instruments during spine surgeries. It uses real-time tracking and intraoperative CT images to navigate and position surgical tools accurately, especially for placing spinal pedicle screws in the thoracic, lumbar, and sacral regions. This helps improve surgical accuracy and patient safety.
Intended Use
Aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube used by surgeons in open or percutaneous spinal procedures, indicated for placement of non-cervical spinal pedicle screws, using intraoperative CT scans.
Technology
An integrated navigation-based robotic platform consisting of two robotic arms and one arm holding a navigation camera, all integrated into a single cart. Uses optical cameras for tracking, force-controlled movements via foot pedal and bracelet, and DICOM format intraoperative CT images for planning and navigation. Supports qualified surgical instruments compliant with specified criteria, with adjustable end effector to accommodate various instrument diameters.
Performance
Comprehensive verification and validation testing including system and instrument verification, navigation accuracy per ASTM F2554-22, quantitative accuracy validation in clinically relevant model, IEC software verification, cybersecurity assessments, electromagnetic and electrical safety testing, biocompatibility, cleaning and sterilization validation, and human factors/usability testing.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/24/2024
6 months - 2
FDA Approval
4/23/2025
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