510(k) Report

Devices descending from K113014

97 later devices reach Claw II Polyaxial Compression System and Ortholoc 3DSI Locking Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200513DAC Dynamic Active Compression PlatePioneer Surgical Technology, Inc., Dba Rti Surgical20200—
+1K121651Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc201295—
+2K221395Footmotion Plating SystemNewclip Technics20220—
+2K212979CalcShift™ Displacement Calcaneal Osteotomy SystemNextremity Solutions, Inc.20220—
+2K182785LOQTEQ VA Foot Plates 2.5Aap Implantate AG20190—
+2K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+2K161448Footmotion Plating SystemNewclip Technics20165—
+2K152974ORTHOLOC® 3Di Foot Plating Reconstruction SystemWrightmedicaltechnologyinc201522—
+2K151442Total Compression Plating (TCP) SystemWrightmedicaltechnologyinc201523—
+2K151407RECON systemNormed Medizin-Technik GmbH20154—
+2K151235Medline Foot Plates and ScrewsMedline Industries, Inc.201510—
+2K143717Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201512—
+2K143025Total Compression Plating SystemWrightmedicaltechnologyinc201424—
+2K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+2K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+3K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+3K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+3K234031Medline UNITE Ancillary Foot Recon Plating SystemMedline Industires, LP20241—
+3K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+3K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+3K220136Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20228—
+3K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+3K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+3K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+3K200062Foot and Ankle SystemLeith Medical, LLC20210—
+3K202959PolyLock Plating SystemFusion Orthopedics, LLC20201—
+3K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+3K192696TriMed ASET Foot Plating SystemTriMed, Inc.20201—
+3K192504Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201910—
+3K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+3K181820Medline Unite Mini Plates and ScrewsMedline Industries, Inc.20182—
+3K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+3K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+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—
+3K171510Footmotion Plating SystemNewclip Technics20171—
+3K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+3K170843Alians Fragment SpecificNewclip Technics20171—
+3K170012Foot and Hand MotionNewclip Technics20170—
+3K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+3K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc.20161—
+3K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+3K153531Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201611—
+3K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+4K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+4K250935TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System…TriMed, Inc.20250—
+4K243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LP20250—
+4K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+4K233863TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating…TriMed, Inc.20240—
+4K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+4K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+4K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+4K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+4K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+4K221181Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20237—
+4K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+4K211843PolyLock Plating SystemFusion Orthopedics20220—
+4K213214Xpert WristNewclip Technics20210—
+4K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+4K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+4K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+4K200961Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20209—
+4K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+4K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+4K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+4K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+5K260810Anteralign LS coverplateTyber Medical, LLC20260—
+5K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+5K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+5K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+5K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+5K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+5K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+5K233017TM Plating SystemTyber Medical, LLC20231—
+5K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+5K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+5K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+5K201149CoLink Plating SystemIn2bones USA, LLC20200—
+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—
+6K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+6K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+6K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+6K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+6K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+6K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+6K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+7K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+7K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+7K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+7K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+7K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+8K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—