510(k) Report

Devices descending from K011716

117 later devices reach The Uni-Clip Staple through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182943VERTEX Nitinol Staple SystemNvision Biomedical Technologies, LLC20190—
+1K153622First Ray Internal Bone Staple SystemFirst Ray, LLC20164—
+1K153395OS2-C Compression StapleIn2bones Sas20167—
+1K112794Eos Small Bone Fixation SystemTriMed, Inc.201294
+1K070688Nexfix Compression StapleNexa Orthopedics, Inc.20070—
+1K061594Large Uni-Clip StapleNew Deal, S.A.2006103—
+2K212594OSSIOfiber® StapleOSSIO, Ltd.20222—
+2K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+2K190166TriMed Nitinol Staple SystemTriMed, Inc.20190—
+2K163440Stealth Staple SystemFirst Ray, LLC20173—
+2K070447Newdeal Compression PlateNewdeal Sas20071022
+3K241932OSSIOfiber® Compression StapleOSSIO, Ltd.20240—
+3K233302OSSIOfiber® Compression StapleOSSIO, Ltd.20231—
+3K220181StealthFix Intraosseous Fixation SystemNextremity Solutions, Inc.20221—
+3K161303dynaMX™ Compression PlateMx Orthopedics, Corp.20171—
+3K093914Newdeal Compression PlatesNewdeal Sas2011985
+3K091609Newdeal Compression PlateNewdeal Sas200921
+4K232324StealthFix Intraosseous Fixation SystemMedartis, Inc.20230—
+4K193345Arthrex DynaNite Compression PlateArthrex, Inc.20200—
+4K113014Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc20129712
+5K200513DAC Dynamic Active Compression PlatePioneer Surgical Technology, Inc., Dba Rti Surgical20200—
+5K121651Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc201295—
+6K221395Footmotion Plating SystemNewclip Technics20220—
+6K212979CalcShift™ Displacement Calcaneal Osteotomy SystemNextremity Solutions, Inc.20220—
+6K182785LOQTEQ VA Foot Plates 2.5Aap Implantate AG20190—
+6K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+6K161448Footmotion Plating SystemNewclip Technics20165—
+6K152974ORTHOLOC® 3Di Foot Plating Reconstruction SystemWrightmedicaltechnologyinc201522—
+6K151442Total Compression Plating (TCP) SystemWrightmedicaltechnologyinc201523—
+6K151407RECON systemNormed Medizin-Technik GmbH20154—
+6K151235Medline Foot Plates and ScrewsMedline Industries, Inc.201510—
+6K143717Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201512—
+6K143025Total Compression Plating SystemWrightmedicaltechnologyinc201424—
+6K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+6K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+7K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+7K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+7K234031Medline UNITE Ancillary Foot Recon Plating SystemMedline Industires, LP20241—
+7K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+7K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+7K220136Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20228—
+7K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+7K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+7K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+7K200062Foot and Ankle SystemLeith Medical, LLC20210—
+7K202959PolyLock Plating SystemFusion Orthopedics, LLC20201—
+7K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+7K192696TriMed ASET Foot Plating SystemTriMed, Inc.20201—
+7K192504Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201910—
+7K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+7K181820Medline Unite Mini Plates and ScrewsMedline Industries, Inc.20182—
+7K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+7K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+7K171690Trident Extremity Fixation SystemTrident Orthopedics20180—
+7K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+7K172886Breakaway Screw SystemParagon 2820174—
+7K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+7K171510Footmotion Plating SystemNewclip Technics20171—
+7K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+7K170843Alians Fragment SpecificNewclip Technics20171—
+7K170012Foot and Hand MotionNewclip Technics20170—
+7K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+7K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc.20161—
+7K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+7K153531Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201611—
+7K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+8K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+8K250935TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System…TriMed, Inc.20250—
+8K243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LP20250—
+8K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+8K233863TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating…TriMed, Inc.20240—
+8K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+8K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+8K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+8K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+8K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+8K221181Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20237—
+8K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+8K211843PolyLock Plating SystemFusion Orthopedics20220—
+8K213214Xpert WristNewclip Technics20210—
+8K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+8K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+8K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+8K200961Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20209—
+8K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+8K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+8K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+8K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+9K260810Anteralign LS coverplateTyber Medical, LLC20260—
+9K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+9K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+9K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+9K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+9K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+9K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+9K233017TM Plating SystemTyber Medical, LLC20231—
+9K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+9K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+9K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+9K201149CoLink Plating SystemIn2bones USA, LLC20200—