510(k) Report

Devices descending from K033639

98 later devices reach Acumed Lower Extremity Congruent Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242973CanMINI Hand and Foot SystemCanwell Medical Co., Ltd.20250—
+1K073375Newdeal Tibiaxys SystemNewdeal Sas2008732
+1K063831Basal Dorsal PlatesNewdeal Sas20070—
+1K063672Fibula Plate Prolock with Angular StabilityI.T.S. Implantat-Technologie-Systeme GmbH2007251
+1K060474Lisfranc PlateNew Deal, S.A.20061—
+1K060476Lapidus PlateNew Deal, S.A.20061—
+2K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+2K202803Activmotion S DTONewclip Technics20210—
+2K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…Integra LifeSciences Corporation20210—
+2K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+2K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+2K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+2K121425Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc201253—
+2K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc.201169—
+2K100176Ascension Ankle Fusion Plate SystemAscension Orthopedics, Inc.201056—
+2K063820Lisfranc PlateNew Deal, S.A.20070—
+2K070241Modification to Lapidus PlateNew Deal, S.A.200701
+3K260274Airlock® Ankle Plating SystemNovastep SAS20260—
+3K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+3K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+3K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+3K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+3K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+3K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+3K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+3K202307Activ FuseNewclip Technics20200—
+3K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+3K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—
+3K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+3K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+3K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc201712—
+3K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+3K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+3K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+3K140408Salvation Osteopenic ScrewWrightmedicaltechnologyinc20141—
+3K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+3K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+3K123347Normed Ankle Fix System 4.0 and Normed Ankle Fix Plus System 4.0Normed Medizin-Technik GmbH201322
+3K120667VLP 2.7MM Extra Large Percutaneous Calcaneus Plate, Peri-Loc 3.5MM Anterior Ankle Fusion…Smith & Nephew, Inc.20129—
+4K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+4K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+4K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+4K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+4K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+4K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+4K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+4K233017TM Plating SystemTyber Medical, LLC20231—
+4K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+4K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+4K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+4K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+4K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+4K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+4K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed20210—
+4K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+4K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+4K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+4K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+4K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+4K172886Breakaway Screw SystemParagon 2820174—
+4K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+4K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+4K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+5K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+5K260810Anteralign LS coverplateTyber Medical, LLC20260—
+5K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+5K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+5K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+5K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+5K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+5K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+5K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+5K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+5K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+5K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+5K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+5K201149CoLink Plating SystemIn2bones USA, LLC20200—
+5K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+5K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+6K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+6K252246Leforte MMF SystemJeil Medical Corporation20260—
+6K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+6K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+6K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+6K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+6K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+6K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+6K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+6K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+6K192592Axis Plating SystemExtremity Medical, LLC20190—
+6K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+7K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+7K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+7K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+7K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+8K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+8K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+8K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123