510(k) Report

Devices descending from K073449

143 later devices reach Surgicase through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K222510Blueprint Mixed Reality systemTornier S.A.S.2023010
+5K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+5K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+5K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+5K210153NextAR RSA PlatformMedacta International S.A.202151
+5K203315BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.202118—
+5K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+5K191247SmartSPACE Shoulder SystemTechmah Medical, LLC20193—
+6K252064MedCAD® AccuStride™ SystemMedcad20260—
+6K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20261—
+6K251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20260—
+6K252847NextAR Hip PlatformMedacta International S.A.20260—
+6K253793Materialise TKA Guide SystemMaterialise NV20260—
+6K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+6K251709MedCAD® AccuStride™ SystemMedcad20250—
+6K250767Newclip Patient-matched instrumentation non sterile PSINewclip Technics20250—
+6K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+6K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+6K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.20250—
+6K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20241—
+6K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.20243—
+6K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+6K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+6K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+6K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+6K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+6K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+6K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301
+6K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+6K222405Smart SPACE Shoulder Planner and 3D PositionersLima Corporate S.P.A.20220—
+6K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Tornier, Inc.202182
+6K202151Smart SPACE Shoulder SystemTechmah Medical, LLC20211—
+6K202454Smart SPACE Shoulder SystemTechmah Medical, LLC20201—
+7K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+7K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+7K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+7K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+7K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20250—
+7K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+7K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+7K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+7K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+8K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)20260—