510(k) Report

Devices descending from K071264

299 later devices reach Synthes (Usa) 2.4/2.7 MM Locking Foot Module through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+4K192619Pitkar Locked Plating SystemS.H.Pitkar Orthotools Pvt., Ltd.20200—
+4K192096Omnia Medical Trauma ScrewsOmnia Medical, LLC20200—
+4K190830TDM Screw SystemsTdm Co., Ltd.20191—
+4K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+4K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+4K173641Activ AnkleNewclip Technics20183—
+4K171372Alians Elbow Locking Plating SystemNewclip Technics20180—
+4K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+4K172886Breakaway Screw SystemParagon 2820174—
+4K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+4K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+4K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+4K170843Alians Fragment SpecificNewclip Technics20171—
+4K170771VariAx 2 Foot SystemStryker GmbH20170—
+4K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+4K163425NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS…Narang Medical USA Corporation20170—
+4K160177Gridlock Ankle Plating SystemTrilliant Surgical, Ltd.201631
+4K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+4K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC201515—
+4K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+4K151769Anchorage 2 CP SystemStryker GmbH20150—
+4K141347Emerge Medical IM Nail SystemEmerge Medical20140—
+5K262344Large Compression ScrewsTriMed, Inc.20260—
+5K261511Xpert AnkleNewclip Technics20260—
+5K260810Anteralign LS coverplateTyber Medical, LLC20260—
+5K260761APTUS Clavicle System 2.8Medartis AG20260—
+5K261241TriMed Compression ScrewsTriMed, Inc.20260—
+5K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20260—
+5K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+5K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)TriMed, Inc.20251—
+5K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+5K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+5K241277OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20241—
+5K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+5K233912ARIX Cannulated Screw SystemJeil Medical Corporation20240—
+5K233198OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd.20242—
+5K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+5K231860TDM Screw SystemTdm Co., Ltd.20240—
+5K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+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—
+5K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+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—
+5K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+5K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd.20224—
+5K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+5K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+5K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd.20214—
+5K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+5K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+5K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+5K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+5K201149CoLink Plating SystemIn2bones USA, LLC20200—
+5K191009Arsenal Plating SystemTrilliant Surgical20192—
+5K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+5K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+5K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+6K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…TriMed, Inc.20260—
+6K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+6K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+6K252246Leforte MMF SystemJeil Medical Corporation20260—
+6K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+6K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+6K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+6K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+6K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+6K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+6K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+6K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+6K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+6K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+6K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+6K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+6K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+6K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+6K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+6K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+6K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+6K192592Axis Plating SystemExtremity Medical, LLC20190—
+6K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+6K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+6K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+7K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+7K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+7K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+7K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+7K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+7K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+7K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+8K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+8K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+8K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+8K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+8K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+9K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—