510(k) Report

Devices descending from K013630

123 later devices reach Isite Radiology through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K191247SmartSPACE Shoulder SystemTechmah Medical, LLC20193—
+11K251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20260—
+11K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.20250—
+11K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.20243—
+11K222405Smart SPACE Shoulder Planner and 3D PositionersLima Corporate S.P.A.20220—
+11K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+11K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Tornier, Inc.202182
+11K202151Smart SPACE Shoulder SystemTechmah Medical, LLC20211—
+11K202454Smart SPACE Shoulder SystemTechmah Medical, LLC20201—
+12K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+12K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+12K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+12K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+12K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+12K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+12K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+12K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+13K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+13K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)20260—
+13K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20261—
+13K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+14K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+14K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—