bffd38a8-a975-4158-aecb-3550be3a3ad7NewPublished12026-04-212026-04-13In Commercial Distribution07630345729316PrimaryGS1NextAR TSA Platform5.3SSWNXAR488227125Medacta International SA1NextAR Shoulder softwarefalsefalsefalsefalsefalsefalsetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety InformationfalsefalseK23228000062782Optical surgical navigation device tracking systemA mobile assembly of electrically-powered devices intended to provide a physician with optical tools to track manual surgical instruments and locate anatomical structures with respect to pre-acquired images (e.g., CT/MRI scan) or real-time data [e.g., endoscopic, ultrasound (US)]; it may be capable of creating digital 3-D patient models. It consists of a workstation with controls/display, position/movement tracking cameras (e.g., infrared), adaptors, and sensors/spatial markers designed to be attached to the patient and instruments. It is used for multiple surgical procedures (e.g., craniotomy, tumour resection) in various fields [e.g., ENT, neurosurgery, CMF surgery].falseActiveSBFOrthopedic Augmented Realityfalsefalse