510(k) Report

Devices descending from K042313

114 later devices reach Integradweb MPR/Mip through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+10K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+10K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+10K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+10K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+10K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+10K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+10K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+11K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+11K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)20260—
+11K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20261—
+11K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+12K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+12K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—