510(k) Report

Devices descending from K091243

102 later devices reach Ortholoc Ankle Plating System (Aps) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc.20161—
+1K142121Valor Hindfoot Fusion Nail SystemWrightmedicaltechnologyinc20144—
+1K102429Ortholoc 3DI Ankle Plating System, Ortholoc Bone ScrewWrightmedicaltechnologyinc2010971
+2K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+2K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+2K213567Medline UNITE Calcaneal Fracture Plating SystemMedline Industries, LP20221—
+2K200062Foot and Ankle SystemLeith Medical, LLC20210—
+2K201259ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating SystemWrightmedicaltechnologyinc20210—
+2K163044ORTHOLOC® 3Di Ankle Fracture Plating SystemWrightmedicaltechnologyinc201713—
+2K160177Gridlock Ankle Plating SystemTrilliant Surgical, Ltd.201631
+2K131093Ortholoc (R) 3DI Ankle Plating SystemWrightmedicaltechnologyinc201326—
+2K121682Active Screw Bone ScrewIntelligent Implant Systems, LLC20120—
+2K120802Ortholoc (TM) 3DI Locking Screws Ortholoc (TM) Bone ScrewsWrightmedicaltechnologyinc201211—
+2K112772Ortholoc (TM) Bone ScrewsWrightmedicaltechnologyinc201168—
+3K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+3K230204ALPHALOK Plating SystemVilex, LLC20230—
+3K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+3K221558ALPHALOK Plating SystemVilex, LLC20222—
+3K213005Apollo Ankle Fracture Plating SystemGlw Medical, Inc.20221—
+3K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+3K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+3K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+3K191009Arsenal Plating SystemTrilliant Surgical20192—
+3K173641Activ AnkleNewclip Technics20183—
+3K170313ARIX Ankle Distal Tibia SystemJeil Medical Corporation20172—
+3K151235Medline Foot Plates and ScrewsMedline Industries, Inc.201510—
+3K143061Activ Ankle Locking Plating SystemNewclip Technics20158—
+3K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+3K121425Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc201253—
+3K121713PMT Bone ScrewsProvidence Medical Technology, Inc.201211
+4K261511Xpert AnkleNewclip Technics20260—
+4K260274Airlock® Ankle Plating SystemNovastep SAS20260—
+4K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+4K234031Medline UNITE Ancillary Foot Recon Plating SystemMedline Industires, LP20241—
+4K221489Artemis Proximal Femoral Nail SystemGlw, Inc.20220—
+4K221395Footmotion Plating SystemNewclip Technics20220—
+4K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+4K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+4K213214Xpert WristNewclip Technics20210—
+4K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+4K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+4K202959PolyLock Plating SystemFusion Orthopedics, LLC20201—
+4K202307Activ FuseNewclip Technics20200—
+4K202912ARIX Ankle Distal Tibia SystemJeil Medical Corporation20201—
+4K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—
+4K181820Medline Unite Mini Plates and ScrewsMedline Industries, Inc.20182—
+4K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+4K171690Trident Extremity Fixation SystemTrident Orthopedics20180—
+4K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+4K170843Alians Fragment SpecificNewclip Technics20171—
+4K170698ALLY (TM) Bone ScrewsProvidence Medical Technology, Inc.20170—
+4K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc201712—
+4K152289Alians Elbow Locking Plating SystemNewclip Technics20166—
+4K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+4K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+5K261191Alians Elbow SNewclip Technics20260—
+5K250935TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System…TriMed, Inc.20250—
+5K243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LP20250—
+5K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+5K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+5K211843PolyLock Plating SystemFusion Orthopedics20220—
+5K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+5K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+5K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+5K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+5K171372Alians Elbow Locking Plating SystemNewclip Technics20180—
+5K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+5K172886Breakaway Screw SystemParagon 2820174—
+5K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+5K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+5K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+6K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+6K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+6K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+6K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+6K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+6K201149CoLink Plating SystemIn2bones USA, LLC20200—
+6K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+6K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+6K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+7K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+7K252246Leforte MMF SystemJeil Medical Corporation20260—
+7K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+7K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+7K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+7K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+7K233017TM Plating SystemTyber Medical, LLC20231—
+7K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+7K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+7K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+7K192592Axis Plating SystemExtremity Medical, LLC20190—
+7K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+8K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+8K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+8K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+8K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+8K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+9K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+9K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+9K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123