510(k) Report

Devices descending from K121640

60 later devices reach Zimmer Patient Specific Instruments System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140027Zimmer Patient Specific Instruments/ System/PlannerMaterialise NV201412—
+1K133162Zimmer Patient Specific Instruments System, Zimmer Patient Specific Instruments, Zimmer…Materialise NV201413—
+1K131409Cas Psi Knee SystemOrthosoft, Inc.201321
+1K131129Cas Psi ShoulderZimmer Cas201339—
+2K193312UNIKO PointCloud™ Knee InstrumentsUnik Orthopedics, Inc.20201—
+2K173445Materialise TKA Guide SystemMaterialise NV201891
+2K171269X-PSI Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20171—
+2K150928Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA GuidesMaterialise NV201512—
+2K150730Zimmer PSI Shoulder SystemZimmer201511—
+2K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201531—
+3K240327UNIKO PointCloud™ Knee InstrumentsUnik Orthopedics, Inc.20240—
+3K230850United Orthopedic Knee Patient Specific InstrumentationEnhatch, Inc.20230—
+3K221337Materialise TKA Guide SystemMaterialise NV202221
+3K190738MyShoulder Placement GuidesMedacta International S.A.20194—
+3K190595Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)201910—
+3K173970Materialise PKA Guide SystemMaterialise NV20185—
+3K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S.20160—
+3K162273Materialise TKA Guide SystemMaterialise NV201611—
+3K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201625—
+4K251554Materialise TKA Guide SystemMaterialise NV20251—
+4K243509Archer PSI System3D-Side20250—
+4K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20242—
+4K212560Signature™ ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20217—
+4K211512VISIONAIRE UK Patient Matched Cutting GuidesSmith & Nephew, Inc.20213—
+4K202207Materialise PKA Guide SystemMaterialise NV20200—
+4K200615Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20208—
+4K192074Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20199—
+4K172650Materialise PKA Guide SystemMaterialise NV20176—
+4K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201723—
+5K253793Materialise TKA Guide SystemMaterialise NV20260—
+5K243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20251—
+5K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc.20242—
+5K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+5K222007Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20233—
+5K203315BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.202118—
+5K191247SmartSPACE Shoulder SystemTechmah Medical, LLC20193—
+6K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20261—
+6K251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20260—
+6K241470CORE Shoulder SystemLinkBio Corp.202501
+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—
+6K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+6K222405Smart SPACE Shoulder Planner and 3D PositionersLima Corporate S.P.A.20220—
+6K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+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—
+7K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+7K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+7K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20250—
+7K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+7K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+7K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+7K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+8K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+8K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)20260—
+8K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+9K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—