510(k) Report

Devices descending from K080875

79 later devices reach Pigalileo 4TH Generation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090420Smith & Nephew Pigalileo Screw Targeting System V 1.0Smith & Nephew, Inc.200978—
+2K092497Smith & Nephew Pigalileo Screw Targeting System, Version 1.1Smith & Nephew, Inc.200977—
+3K180277Smith & Nephew SURESHOT Distal Targeting System V4.0 TargeterSmith & Nephew, Inc.20180—
+3K170280Smith & Nephew SURESHOT Distal Targeting System V4.0Smith & Nephew, Inc.20170—
+3K130748Smith & Nephew Sureshot Distal Targeting System V3.0Smith & Nephew, Inc.20131—
+3K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc.201169—
+3K110240Smith & Nephew, Inc. Sureshot Distal Targeting System V2.1Smith & Nephew, Inc.20112—
+3K102967Smith & Nephew, Inc. Sureshot Distal Targeting System V2.0.2Smith & Newphew, Inc.20103—
+3K100107Smith & Nephew Sureshot Distal Targeting System V2.0Smith & Nephew, Inc.2010751
+4K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+4K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+4K170977SURESHOT Distal Targeting System V4.0 Trauma InterfaceSmith & Nephew, Inc.20170—
+4K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+4K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+4K140408Salvation Osteopenic ScrewWrightmedicaltechnologyinc20141—
+4K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+4K123347Normed Ankle Fix System 4.0 and Normed Ankle Fix Plus System 4.0Normed Medizin-Technik GmbH201322
+4K121425Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc201253—
+4K120667VLP 2.7MM Extra Large Percutaneous Calcaneus Plate, Peri-Loc 3.5MM Anterior Ankle Fusion…Smith & Nephew, Inc.20129—
+5K260274Airlock® Ankle Plating SystemNovastep SAS20260—
+5K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+5K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+5K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+5K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+5K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+5K233017TM Plating SystemTyber Medical, LLC20231—
+5K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+5K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+5K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+5K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+5K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed20210—
+5K202307Activ FuseNewclip Technics20200—
+5K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—
+5K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+5K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+5K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc201712—
+5K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+5K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+6K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+6K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+6K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+6K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+6K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+6K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+6K172886Breakaway Screw SystemParagon 2820174—
+6K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+6K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+6K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+7K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+7K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+7K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+7K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+7K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+7K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+7K201149CoLink Plating SystemIn2bones USA, LLC20200—
+7K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+7K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+7K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+8K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+8K252246Leforte MMF SystemJeil Medical Corporation20260—
+8K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+8K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+8K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+8K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+8K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+8K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+8K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+8K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+8K192592Axis Plating SystemExtremity Medical, LLC20190—
+8K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+9K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+9K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+9K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+9K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+10K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+10K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+10K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+11K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+12K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—