NextAR(TM) Spine
Medacta International S.A.NextAR Spine is an augmented reality surgical navigation platform designed to help surgeons precisely locate anatomical structures during spine surgery. It uses CT imaging and intraoperative scans to guide the placement of screws and other instruments in the thoracic and lumbosacral spine, improving surgical accuracy and patient outcomes.
Intended Use
The NextAR Spine platform is intended as an aid for precisely locating anatomical structures in either open/mini-open or percutaneous spine procedures, including pedicle screw placement and sacro-iliac screw placement. It provides planning tools for measuring and selecting fixation rods for the thoracic and lumbosacral spine. It incorporates stereotaxic surgery principles and can be used with augmented reality glasses as an optional display.
Technology
The system includes navigation software, augmented reality glasses, an optical tracking system, PC-based hardware, fiducial blocks, and surgical instruments. It relies on stereotaxic technology with infrared camera tracking of instruments and bones in real-time. The platform can register spine anatomy using intra-operative 3D scans or combined pre-operative CT and intra-operative 3D scans. Planning tools allow visualization of screw trajectories and rod planning in real-time.
Performance
Verification and validation activities include software testing, comparative evaluations demonstrating instrument equivalence to predicate devices, and cadaver workshops showing suitability for intended use. No clinical studies were conducted.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/19/2025
5 months - 2
FDA Approval
7/31/2025
Other devices from Medacta International S.A.
- MySpine WebPlanner2025 • 510K
- MyShoulder Planner (5.3SSWPL)2025 • 510K
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