510(k) Report

Devices descending from K112772

68 later devices reach Ortholoc (TM) Bone Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121682Active Screw Bone ScrewIntelligent Implant Systems, LLC20120—
+1K121425Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc201253—
+1K121713PMT Bone ScrewsProvidence Medical Technology, Inc.201211
+1K120802Ortholoc (TM) 3DI Locking Screws Ortholoc (TM) Bone ScrewsWrightmedicaltechnologyinc201211—
+2K260274Airlock® Ankle Plating SystemNovastep SAS20260—
+2K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+2K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+2K202307Activ FuseNewclip Technics20200—
+2K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—
+2K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+2K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+2K170698ALLY (TM) Bone ScrewsProvidence Medical Technology, Inc.20170—
+2K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc201712—
+2K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+2K151235Medline Foot Plates and ScrewsMedline Industries, Inc.201510—
+2K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+3K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+3K234031Medline UNITE Ancillary Foot Recon Plating SystemMedline Industires, LP20241—
+3K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+3K202959PolyLock Plating SystemFusion Orthopedics, LLC20201—
+3K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+3K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+3K181820Medline Unite Mini Plates and ScrewsMedline Industries, Inc.20182—
+3K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+3K171690Trident Extremity Fixation SystemTrident Orthopedics20180—
+3K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+3K172886Breakaway Screw SystemParagon 2820174—
+3K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+3K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+3K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+3K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc.20161—
+4K250935TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System…TriMed, Inc.20250—
+4K243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LP20250—
+4K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+4K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+4K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+4K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+4K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+4K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+4K211843PolyLock Plating SystemFusion Orthopedics20220—
+4K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+4K201149CoLink Plating SystemIn2bones USA, LLC20200—
+4K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+4K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+4K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+5K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+5K252246Leforte MMF SystemJeil Medical Corporation20260—
+5K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+5K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+5K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+5K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+5K233017TM Plating SystemTyber Medical, LLC20231—
+5K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+5K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+5K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+5K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+5K192592Axis Plating SystemExtremity Medical, LLC20190—
+5K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+6K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+6K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+6K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+6K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+6K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+7K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+7K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+7K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+8K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+9K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—