510(k) Report

Devices descending from K162800

23 later devices reach BLUEPRINT Patient Specific Instrumentation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203315BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.202118—
+1K191247SmartSPACE Shoulder SystemTechmah Medical, LLC20193—
+2K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.20250—
+2K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.20243—
+2K222405Smart SPACE Shoulder Planner and 3D PositionersLima Corporate S.P.A.20220—
+2K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+2K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Tornier, Inc.202182
+2K202151Smart SPACE Shoulder SystemTechmah Medical, LLC20211—
+2K202454Smart SPACE Shoulder SystemTechmah Medical, LLC20201—
+3K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+3K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+3K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+3K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+3K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+3K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+3K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+3K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+4K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+4K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)20260—
+4K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20261—
+4K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+5K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+5K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—