510(k) Report

Devices descending from K112389

59 later devices reach Surgicase Connect, Surgicase Guide through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201531—
+1K132290Surgicase Orthopaedics System, Surgicase Connect, Surgicase GuidesMaterialise NV201418—
+1K131129Cas Psi ShoulderZimmer Cas201339—
+2K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+2K190738MyShoulder Placement GuidesMedacta International S.A.20194—
+2K170419SurgiCase ViewerMaterialise NV20173—
+2K163156SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase GuidesMaterialise NV20178—
+2K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S.20160—
+2K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201625—
+2K150730Zimmer PSI Shoulder SystemZimmer201511—
+3K260116CustoMED ViewerCustoMED, Ltd.20260—
+3K243509Archer PSI System3D-Side20250—
+3K240415Newclip Patient-matched instrumentation non sterile PSINewclip Technics20242—
+3K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20242—
+3K221615Newclip Patient-matched instrumentation non sterile PSINewclip Technics20233—
+3K213684SurgiCase ViewerMaterialise NV20221—
+3K220717RedPoint Medical's Better Bunion SystemRedpoint Medical, LLC20223—
+3K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+3K190595Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)201910—
+3K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201723—
+4K260206SkeletonPlannerUPlanner B.V. - Presurgeo20260—
+4K241811MedCAD® AccuStride™ SystemMedcad20252—
+4K243912Newclip Patient-matched instrumentation non sterile PSINewclip Technics20251—
+4K243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20251—
+4K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+4K212560Signature™ ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20217—
+4K203315BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.202118—
+4K200615Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20208—
+4K191247SmartSPACE Shoulder SystemTechmah Medical, LLC20193—
+4K192074Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20199—
+5K252064MedCAD® AccuStride™ SystemMedcad20260—
+5K251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20260—
+5K251709MedCAD® AccuStride™ SystemMedcad20250—
+5K250767Newclip Patient-matched instrumentation non sterile PSINewclip Technics20250—
+5K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.20250—
+5K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.20243—
+5K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+5K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+5K222007Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20233—
+5K222405Smart SPACE Shoulder Planner and 3D PositionersLima Corporate S.P.A.20220—
+5K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+5K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Tornier, Inc.202182
+5K202151Smart SPACE Shoulder SystemTechmah Medical, LLC20211—
+5K202454Smart SPACE Shoulder SystemTechmah Medical, LLC20201—
+6K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20261—
+6K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+6K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+6K241470CORE Shoulder SystemLinkBio Corp.202501
+6K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+6K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+6K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+6K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+6K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+6K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+7K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+7K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+7K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)20260—
+7K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+8K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—