Device Dossier
Optical surgical navigation device tracking system
Device Dossier for Optical surgical navigation device tracking system (Optical surgical navigation device tracking system, Class IIa, sponsor Medacta).…
- GMDN category: Optical surgical navigation device tracking system
Intended purpose
The Shoulder NextAR™ Platform supports the surgeon during glenoid implantation in shoulder replacement procedures providing information on bone preparation, instrument guidance, and implant positioning. The Shoulder NextAR™ Platform works in conjunction with NextAR™ stereotaxic instruments and general surgical instruments to implant the Medacta Shoulder System. As an optional display, the smart glasses can be used auxiliary to the Shoulder NextAR™ Platform to view the same 2D stereotaxic information as presented by the Shoulder NextAR™ Platform. The Shoulder NextAR™ stereotaxic instruments are to support the surgeon during specific orthopedic surgical procedures by providing information on bone preparation, instrument guidance, and implant positioning. Once registered, the NextAR™ stereotaxic instruments provide reference to a patient's rigid anatomical structures on the surface of the glenoid that are identified relative to preoperative C.T. based planning. The smart glasses should not be relied upon solely and should always be used in conjunction with the primary computer display.