510(k) Report

Devices descending from K061362

126 later devices reach Pigalileo Total Knee Replacement (TKR) System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102990Brainlab KneeBrainlab AG201171
+1K083872Imns Medacta Navigation SystemMedacta International S.A.200914—
+1K082267Pigalileo Cas, Version 4.0 and TKR Base, Version 2.1Smith & Nephew, Inc.20081—
+1K081232Total Knee Surgetics Navigation System with PraxitelesPraxim200818—
+1K080875Pigalileo 4TH Generation SystemSmith & Nephew, Inc.200879—
+1K070731Pigalileo Total Hip Replacement (THR) SystemPlus Orthopedics AG200781—
+2K220652Knee 3Brainlab AG20220—
+2K193559NextAR TKA PlatformMedacta Inernational SA202012—
+2K122011Navigation Software Hip-Universal; Navigation Software Hip THR-AesculapBrainlab AG201251
+2K100314Imns Medacta Navigation System,33.221000USMedacta International S.A.201013—
+2K090953Total Knee Surgetics Navigation System with IblockPraxim Medivision, SA2010172
+2K090420Smith & Nephew Pigalileo Screw Targeting System V 1.0Smith & Nephew, Inc.200978—
+2K090313Pigalileo TKR Base V2.3 and Cas V4.1Smith & Nephew, Inc.20090—
+2K083565Pigalileo Total Hip Replacement (THR) Software Application V3.0Smith & Nephew, Inc.20090—
+3K252847NextAR Hip PlatformMedacta International S.A.20260—
+3K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+3K213751NextAR™ TKA Platform My Knee PPSMedacta International S.A.20220—
+3K210859NextAR™ Spine PlatformMedacta International S.A.20214—
+3K210153NextAR RSA PlatformMedacta International S.A.202151
+3K202769VELYS™ Robotic-Assisted SolutionDepuy Ireland UC202131
+3K202152NextAR TKA PlatformMedacta International S.A.202011—
+3K193307HIP7Brainlab AG20200—
+3K181449Ortoma Treatment Solution - OTSOrtoma AB20183—
+3K163338OMNIBotics Knee SystemOmnllife Science, Inc.201712—
+3K092497Smith & Nephew Pigalileo Screw Targeting System, Version 1.1Smith & Nephew, Inc.200977—
+4K250477NextAR (TM) SpineMedacta International S.A.20250—
+4K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+4K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+4K232140OTS HipOrtoma AB202421
+4K233227VELYS™ Robotic-Assisted SolutionDepuy Ireland UC20231—
+4K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+4K223769NextAR™ Spine PlatformMedacta International S.A.20232—
+4K200888OMNIBotics Knee SystemCorin, Ltd.202011—
+4K180277Smith & Nephew SURESHOT Distal Targeting System V4.0 TargeterSmith & Nephew, Inc.20180—
+4K170280Smith & Nephew SURESHOT Distal Targeting System V4.0Smith & Nephew, Inc.20170—
+4K130748Smith & Nephew Sureshot Distal Targeting System V3.0Smith & Nephew, Inc.20131—
+4K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc.201169—
+4K110240Smith & Nephew, Inc. Sureshot Distal Targeting System V2.1Smith & Nephew, Inc.20112—
+4K102967Smith & Nephew, Inc. Sureshot Distal Targeting System V2.0.2Smith & Newphew, Inc.20103—
+4K100107Smith & Nephew Sureshot Distal Targeting System V2.0Smith & Nephew, Inc.2010751
+5K260480VELYS™ Robotic-Assisted SolutionDepuy Ireland UC20260—
+5K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+5K250086OTS HipOrtoma AB202511
+5K233172NextAR™ Spine PlatformMedacta International S.A.20241—
+5K231172ApolloKneeCorin U.S.A. Limited20230—
+5K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+5K221224Real Intelligence CoriBlue Belt Technologies, Inc.20229—
+5K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+5K170977SURESHOT Distal Targeting System V4.0 Trauma InterfaceSmith & Nephew, Inc.20170—
+5K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+5K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+5K140408Salvation Osteopenic ScrewWrightmedicaltechnologyinc20141—
+5K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+5K123347Normed Ankle Fix System 4.0 and Normed Ankle Fix Plus System 4.0Normed Medizin-Technik GmbH201322
+5K121425Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc201253—
+5K120667VLP 2.7MM Extra Large Percutaneous Calcaneus Plate, Peri-Loc 3.5MM Anterior Ankle Fusion…Smith & Nephew, Inc.20129—
+6K261852OTS HipOrtoma AB20260—
+6K260274Airlock® Ankle Plating SystemNovastep SAS20260—
+6K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+6K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+6K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+6K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+6K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc.20242—
+6K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+6K233017TM Plating SystemTyber Medical, LLC20231—
+6K231963Real Intelligence™ Cori™Blue Belt Technologies, Inc.202342
+6K230876RI.KNEE Adjustable Tibia Cut GuideEnztec Limited20230—
+6K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+6K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+6K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+6K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+6K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed20210—
+6K202307Activ FuseNewclip Technics20200—
+6K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—
+6K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+6K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+6K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc201712—
+6K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+6K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+7K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+7K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20241—
+7K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+7K240139Real Intelligence™ CORI™Blue Belt Technologies, Inc.202431
+7K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+7K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+7K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+7K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+7K172886Breakaway Screw SystemParagon 2820174—
+7K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+7K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+7K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+8K260601Real Intelligence™ Cori™Blue Belt Technologies, Inc.20260—
+8K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+8K251971RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip…Stryker Instruments20250—
+8K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20250—
+8K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+8K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+8K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+8K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+8K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—