510(k) Report

Devices descending from K963221

160 later devices reach Optical Digitizer Option for View Point through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K983764Viewpoint Tools- SterradPhilips Medical Systems (Cleveland), Inc.19990—
+1K970604Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc.1997159—
+2K984298Z Kat Flurotactic Guidance System MkiZ-Kat, Inc.1999152—
+2K990868Viewpoint Passive Tool OptionPhilips Medical Systems (Cleveland), Inc.19991—
+2K990860Viewpoint Microscope OptionPhilips Medical Systems (Cleveland), Inc.19990—
+2K981480Philips EasyguidePhilips Medical Systems, Inc.19990—
+2K984398Liquichek Ana Control, Homogeneous Pattern, Model 201Bio-Rad19980—
+3K013025Modification to Flourolab PlusZ-Kat, Inc.2001151—
+3K991943MRGP Optical Tracking UnitPhilips Medical Systems (Cleveland), Inc.19990—
+4K031454Acumen Surgical Navigation SystemBiomet, Inc.2004146—
+4K031732Ebi Acumen Surgical Navigation SystemEbi, L.P.20030—
+4K031337Acumen Surgical Navigation SystemBiomet, Inc.200381—
+5K111863Signature Planner,Signature GuidesMaterialise NV201271—
+5K081867Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp.2008762
+5K072806Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp.2008781
+5K043223Depuy Cas Knee InstrumentationDePuy Orthopaedics, Inc.200511
+6K162719iTotal® Hip Replacement SystemConformis, Inc.2017174
+6K152893Corin Optimized Positioning System (OPS)Corin USA20168—
+6K150780Acetabular Cup Orientation SystemMaterialise NV20150—
+6K140596NAVIOBlue Belt Technologies, Inc.201421—
+6K131559Match Point System (TM), Surgicase Connect, Match Point System (TM) GuidesMaterialise NV201335—
+6K130126Signature Personalized Patient Care System - Glenoid Guide SystemBiomet, Inc.201338—
+6K121936NaviopfsBlue Belt Technologies, Inc.2012222
+6K112507Restoris Partial Knee Application (Pka), Rio Standard SystemMako Surgical Corporation2012466
+6K093425Mako Surgical Corp Robotic Arm Interactive Orthopedic System-ThaMako Surgical Corp.2010112
+6K091998Robotic Arm Interactive Orthopedic System-HipMako Surgical Corp.200912—
+6K083644Mako Surgical Tactile Guidance System-HipMako Surgical Corp.200913—
+6K053348Stryker Orthopaedics Rfid InstrumentationHowmedica Osteonics Corp.20060—
+7K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+7K202484Cordera Hip SystemConformis, Inc.202022
+7K192198Conformis Hip SystemConformis, Inc.2019121
+7K190904Conformis BeneFIT Hip SystemConformis, Inc.201961
+7K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA20195—
+7K190595Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)201910—
+7K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181—
+7K170584Mako Partial Knee ApplicationMako Surgical Corp.201722
+7K153602Materialise Glenoid Positioning SystemMaterialise NV201621
+7K142530Partial Knee Application (PKA)Mako Surgical Corporation20153—
+7K143752Total Knee Application (TKA)Mako Surgical Corp.2015442
+7K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201531—
+7K143668NavioBlue Belt Technologies, Inc.201520—
+7K121765Sculptor Robotic Guidance Arm (Rga)Stanmore Implants Worldwide, Ltd.20130—
+7K121064Makoplasty Total Hip Application, Rio Standard SystemMako Surgical Corporation2012912
+8K252067Velora Acetabular SystemRestor3D, Inc.20250—
+8K242121mBôs (Monogram mBôs TKA System)Monogram Orthopaedics, Inc.20250—
+8K231178ACTERA™ hip systemConformis, Inc.20230—
+8K221104Actera™ hip systemConformis, Inc.202211
+8K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+8K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+8K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+8K212560Signature™ ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20217—
+8K210121ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20211—
+8K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+8K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+8K200615Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20208—
+8K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+8K190738MyShoulder Placement GuidesMedacta International S.A.20194—
+8K192074Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20199—
+8K172054Materialise Glenoid Positioning SystemMaterialise NV20170—
+8K170893Materialise Glenoid Positioning SystemMaterialise NV201711
+8K170891Mako Partial Knee ApplicationMako Surgical Corp.201723
+8K170581Mako Total Knee ApplicationMako Surgical Corp.2017381
+8K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S.20160—
+8K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201625—
+8K152574NavioBlue Belt Technologies, Inc.201519—
+8K141989Makoplasty Total Hip Allpication, Rio Standard SystemMako Surgical Corporation201483
+9K243509Archer PSI System3D-Side20250—
+9K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20242—
+9K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+9K232533ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20230—
+9K222007Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20233—
+9K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+9K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+9K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+9K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+9K172301Mako Partial Knee ApplicationMako Surgical Corp.201716
+9K172219Mako Total Knee ApplicationMako Surgical Corp.201737—
+9K170593Mako Total Hip ApplicationMako Surgical Corp.201771
+9K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201723—
+9K160537NavioBlue Belt Technologies, Inc.201618—
+10K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20261—
+10K241470CORE Shoulder SystemLinkBio Corp.202501
+10K243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20251—
+10K242373Mako Shoulder Application (1.0)Mako Surgical Corp.20240—
+10K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+10K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+10K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+10K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301
+10K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+10K203315BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.202118—
+10K191247SmartSPACE Shoulder SystemTechmah Medical, LLC20193—
+10K191998Mako Total Hip Application, Mako Total Knee ApplicationMako Surgical Corp.20196—
+10K182964ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)201929—
+10K170360NAVIOBlue Belt Technologies, Inc.201717—
+11K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+11K252058ROSA Knee System with UltraSound Imaging Platform (USIP)Balmoral Medical, LLC20260—
+11K251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20260—
+11K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+11K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.20250—
+11K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—