510(k) Report

Devices descending from K111863

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162719iTotal® Hip Replacement SystemConformis, Inc.2017174
+1K152893Corin Optimized Positioning System (OPS)Corin USA20168—
+1K150780Acetabular Cup Orientation SystemMaterialise NV20150—
+1K131559Match Point System (TM), Surgicase Connect, Match Point System (TM) GuidesMaterialise NV201335—
+1K130126Signature Personalized Patient Care System - Glenoid Guide SystemBiomet, Inc.201338—
+2K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+2K202484Cordera Hip SystemConformis, Inc.202022
+2K192198Conformis Hip SystemConformis, Inc.2019121
+2K190904Conformis BeneFIT Hip SystemConformis, Inc.201961
+2K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA20195—
+2K190595Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)201910—
+2K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181—
+2K153602Materialise Glenoid Positioning SystemMaterialise NV201621
+2K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201531—
+3K252067Velora Acetabular SystemRestor3D, Inc.20250—
+3K231178ACTERA™ hip systemConformis, Inc.20230—
+3K221104Actera™ hip systemConformis, Inc.202211
+3K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+3K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+3K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+3K212560Signature™ ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20217—
+3K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+3K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+3K200615Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20208—
+3K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+3K190738MyShoulder Placement GuidesMedacta International S.A.20194—
+3K192074Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20199—
+3K172054Materialise Glenoid Positioning SystemMaterialise NV20170—
+3K170893Materialise Glenoid Positioning SystemMaterialise NV201711
+3K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S.20160—
+3K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201625—
+4K243509Archer PSI System3D-Side20250—
+4K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20242—
+4K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+4K222007Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20233—
+4K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+4K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+4K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+4K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+4K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201723—
+5K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20261—
+5K241470CORE Shoulder SystemLinkBio Corp.202501
+5K243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20251—
+5K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+5K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+5K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+5K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301
+5K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+5K203315BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.202118—
+5K191247SmartSPACE Shoulder SystemTechmah Medical, LLC20193—
+6K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+6K251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20260—
+6K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+6K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.20250—
+6K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+6K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.20243—
+6K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+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—
+7K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+7K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+7K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+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—