510(k) Report

Devices descending from K190929

31 later devices reach xvision Spine system (XVS) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233725Spine Navigation SystemMedivis, Inc.20240—
+1K220146VisARNovarad Corporation20220—
+1K211188xvision Spine system (XVS)Augmedics, Ltd.202181
+1K202750Knee+Pixee Medical20218—
+1K193559NextAR TKA PlatformMedacta Inernational SA202012—
+2K252847NextAR Hip PlatformMedacta International S.A.20260—
+2K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+2K220905xvision Spine SystemAugmedics, Ltd.20227—
+2K220104Knee+Pixee Medical20227—
+2K213751NextAR™ TKA Platform My Knee PPSMedacta International S.A.20220—
+2K210859NextAR™ Spine PlatformMedacta International S.A.20214—
+2K210153NextAR RSA PlatformMedacta International S.A.202151
+2K202152NextAR TKA PlatformMedacta International S.A.202011—
+3K250477NextAR (TM) SpineMedacta International S.A.20250—
+3K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+3K241525ExcelsiusXR™Globus Medical, Inc.20250—
+3K241481xvision Spine SystemAugmedics, Ltd.20243—
+3K232176STELLAR KneePolarisar, Inc.20230—
+3K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+3K231284OnPoint Augmented Reality Spine SystemOnpoint Surgical, Inc.20231—
+3K223769NextAR™ Spine PlatformMedacta International S.A.20232—
+3K230789Knee+Pixee Medical20235—
+4K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+4K250255xvision Spine systemAugmedics, Ltd.20252—
+4K241870OnPoint Augmented Reality Spine SystemOnpoint Surgical, Inc.20240—
+4K233172NextAR™ Spine PlatformMedacta International S.A.20241—
+4K233899Knee+Pixee Medical20244—
+5K251639xvision Spine systemAugmedics, Ltd.20251—
+5K243975Knee+Pixee Medical20253—
+6K261854xvision Spine systemAugmedics, Ltd.20260—
+6K253805Knee+Pixee Medical S.A.S.20260—