510(k) Report

Devices descending from K955092

219 later devices reach Accurad Image Management System, Autorad, Regustration Station, Archive… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+12K222405Smart SPACE Shoulder Planner and 3D PositionersLima Corporate S.P.A.20220—
+12K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+12K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Tornier, Inc.202182
+12K202151Smart SPACE Shoulder SystemTechmah Medical, LLC20211—
+12K202454Smart SPACE Shoulder SystemTechmah Medical, LLC20201—
+13K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+13K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+13K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+13K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+13K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+13K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+13K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+13K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+14K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+14K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)20260—
+14K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20261—
+14K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+15K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+15K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—