510(k) Report

Devices descending from K102795

99 later devices reach Signature Planner; Signature Guides through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190904Conformis BeneFIT Hip SystemConformis, Inc.201961
+1K150928Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA GuidesMaterialise NV201512—
+1K140257Signature Planner, Signature GuidesMaterialise NV20140—
+1K121640Zimmer Patient Specific Instruments SystemMaterialise NV2012601
+1K111863Signature Planner,Signature GuidesMaterialise NV201271—
+1K113829Zimmer Patient Specific Instrument System Zimmer Patient Specific Instruments Zimmer…Materialise NV201213—
+1K110415Signature Planner / Signature GuidesMaterialise NV2011131
+2K252067Velora Acetabular SystemRestor3D, Inc.20250—
+2K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+2K202484Cordera Hip SystemConformis, Inc.202022
+2K173970Materialise PKA Guide SystemMaterialise NV20185—
+2K173445Materialise TKA Guide SystemMaterialise NV201891
+2K162719iTotal® Hip Replacement SystemConformis, Inc.2017174
+2K162273Materialise TKA Guide SystemMaterialise NV201611—
+2K152893Corin Optimized Positioning System (OPS)Corin USA20168—
+2K150780Acetabular Cup Orientation SystemMaterialise NV20150—
+2K140027Zimmer Patient Specific Instruments/ System/PlannerMaterialise NV201412—
+2K133162Zimmer Patient Specific Instruments System, Zimmer Patient Specific Instruments, Zimmer…Materialise NV201413—
+2K131559Match Point System (TM), Surgicase Connect, Match Point System (TM) GuidesMaterialise NV201335—
+2K131409Cas Psi Knee SystemOrthosoft, Inc.201321
+2K131129Cas Psi ShoulderZimmer Cas201339—
+2K130126Signature Personalized Patient Care System - Glenoid Guide SystemBiomet, Inc.201338—
+2K112301Zimmer Patient Specific Instruments PlannerMaterialise NV20127—
+3K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+3K221104Actera™ hip systemConformis, Inc.202211
+3K221337Materialise TKA Guide SystemMaterialise NV202221
+3K211512VISIONAIRE UK Patient Matched Cutting GuidesSmith & Nephew, Inc.20213—
+3K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+3K202207Materialise PKA Guide SystemMaterialise NV20200—
+3K193312UNIKO PointCloud™ Knee InstrumentsUnik Orthopedics, Inc.20201—
+3K192198Conformis Hip SystemConformis, Inc.2019121
+3K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA20195—
+3K190595Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)201910—
+3K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181—
+3K171269X-PSI Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20171—
+3K172650Materialise PKA Guide SystemMaterialise NV20176—
+3K153602Materialise Glenoid Positioning SystemMaterialise NV201621
+3K150730Zimmer PSI Shoulder SystemZimmer201511—
+3K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201531—
+4K251554Materialise TKA Guide SystemMaterialise NV20251—
+4K240327UNIKO PointCloud™ Knee InstrumentsUnik Orthopedics, Inc.20240—
+4K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc.20242—
+4K230850United Orthopedic Knee Patient Specific InstrumentationEnhatch, Inc.20230—
+4K231178ACTERA™ hip systemConformis, Inc.20230—
+4K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+4K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+4K212560Signature™ ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20217—
+4K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+4K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+4K200615Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20208—
+4K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+4K190738MyShoulder Placement GuidesMedacta International S.A.20194—
+4K192074Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20199—
+4K172054Materialise Glenoid Positioning SystemMaterialise NV20170—
+4K170893Materialise Glenoid Positioning SystemMaterialise NV201711
+4K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S.20160—
+4K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201625—
+5K253793Materialise TKA Guide SystemMaterialise NV20260—
+5K243509Archer PSI System3D-Side20250—
+5K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20241—
+5K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20242—
+5K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+5K222007Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20233—
+5K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+5K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+5K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+5K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201723—
+6K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20261—
+6K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20250—
+6K241470CORE Shoulder SystemLinkBio Corp.202501
+6K243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20251—
+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—
+6K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+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—
+6K203315BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.202118—
+6K191247SmartSPACE Shoulder SystemTechmah Medical, LLC20193—
+7K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+7K251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20260—
+7K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+7K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.20250—
+7K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+7K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.20243—
+7K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+7K222405Smart SPACE Shoulder Planner and 3D PositionersLima Corporate S.P.A.20220—
+7K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+7K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Tornier, Inc.202182
+7K202151Smart SPACE Shoulder SystemTechmah Medical, LLC20211—
+7K202454Smart SPACE Shoulder SystemTechmah Medical, LLC20201—
+8K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+8K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+8K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+8K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+8K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+9K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+9K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)20260—
+9K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+10K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—