510(k) Report

Devices descending from K002775

719 later devices reach Distal Volar Radius Fracture Repair System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102597Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd.201115—
+1K102156Maxlock Extreme Extremity Plating System Distal Radius Plates and ScrewsOrthohelix Surgical Designs, Inc.20101191
+1K090091Olecranail Intramedullary Fixation SystemMylad Orthopedic Solutions, LLC20091—
+1K052150Volar Plate SystemDvo Extremity Solutions, LLC20050—
+1K051567Aptus Titanium Osteosynthesis SystemMedartis, Inc.20051571
+1K041461Kmi Distal Volar Radius Plate SystemKinetikos Medical, Inc.20040—
+1K040908Ebi Distal Radius Plating SystemEbi, L.P.20044—
+1K023007Distal Radius Fracture Repair SystemHand Innovations, Inc.2002681—
+2K253906Xpert HandNewclip Technics20260—
+2K243469SignexOsteonic Co., Ltd.20250—
+2K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+2K232144Sterile Products of the APTUS SystemMedartis AG20233—
+2K213864Bonebridge Osteosynthesis Plating SystemBonebridge AG20228—
+2K213214Xpert WristNewclip Technics20210—
+2K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+2K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+2K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+2K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+2K181009APTUS CMC-I Fusion Plate SystemMedartis AG20180—
+2K180348Field Orthopaedics Micro Screw SystemField Orthopaedics Pty, Ltd.20183—
+2K171624IXOS Radius Plate SystemStuckenbrock Medizintechnik GmbH20180—
+2K172170APTUS (R) Wrist 2.5 SystemMedartis AG20178—
+2K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+2K160995NEOVIEW Plating SystemIn2bones Sas201624
+2K153716GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.Gpc Medical, Ltd.201615—
+2K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+2K142906APTUS Wrist 2.5 SystemMedartis AG201559—
+2K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+2K141232Aptus Ulna Shortening 2.5Medartis AG201451
+2K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc.2014462
+2K132769Acumed Hand Plating SystemAcumed, LLC20147—
+2K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+2K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+2K113048Maxlock Extreme SystemOrthohelix Surgical Designs, Inc.201252—
+2K112169Aptus Wrist Arthrodesis PlatesMedartis AG20128—
+2K110271Maestro Wrist Plating SystemBiomet Manufacturing Corp20110—
+2K111041Mini Variable SystemOrthohelix Surgical Designs, Inc.201177—
+2K101930Memometal Navis Bone Plating SystemMemometal Technologies20110—
+2K110322Olecra Intramedullary Fixation SystemMylad Orthopedic Solutions20110—
+2K103332Aptus Ulna PlatesMedartis AG201171—
+2K102537Aptus 1.5 TrilockMedartis AG201019—
+2K093761Optilock VL (Variable Angle Locking) Distal Radius Plating SystemBiomet Trauma (Aka Ebi, Lp)20103—
+2K062498Profyle SystemHowmedica Osteonics Corp.2006811
+2K052294Shoulder Nail PlateHand Innovations, LLC20050—
+2K052248Dorsal Nail Plate, AnatomicalHand Innovations, LLC200535
+2K030198Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc.2003678—
+3K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+3K260761APTUS Clavicle System 2.8Medartis AG20260—
+3K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+3K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+3K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+3K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG20251—
+3K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA…Bonebridge AG20241—
+3K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+3K241695Extremity All Suture SystemField Orthopaedics20240—
+3K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+3K234062APTUS Hand Scaphoid PlatesMedartis AG20243—
+3K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+3K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+3K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Bonebridge AG20237—
+3K222624KLS Martin LINOS Wrist SystemKLS-Martin L.P.20235—
+3K223853Medartis APTUS® Ulna PlatesMedartis AG20235—
+3K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+3K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+3K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+3K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+3K211592Avanti Orthopaedics Ulnar Shortening SystemAvanti Orthopaedics, Inc.20211—
+3K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+3K201962Skeletal Dynamics Ulnar Shortening Plating SystemSkeletal Dynamics, Inc.20200—
+3K201656ARIX Elbow SystemJeil Medical Corporation20200—
+3K193554APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 SystemMedartis AG20208—
+3K191118Avanti Distal Radius and Forearm SystemAvanti Orthopaedics, Inc.20191—
+3K191972ARIX Wrist SystemJeil Medical Corporation20190—
+3K192297APTUS Wrist Arthrodesis PlatesMedartis AG20197—
+3K191848APTUS Wrist Spanning Plates 2.5Medartis AG20192—
+3K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+3K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—
+3K180500VariAx 2 SystemStryker GmbH201812—
+3K171808TDM Plate and Screw SystemTdm Co., Ltd.20186—
+3K170843Alians Fragment SpecificNewclip Technics20171—
+3K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+3K161861APTUS® Coronoid 2.0Medartis AG20170—
+3K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc.20160—
+3K161037Tarsa-Link Stand-Alone Wedge Fixation SystemLife Spine, Inc.20169—
+3K153379AxSOS 3TiStryker GmbH201625—
+3K153034aap LOQTEQ VA Radius Set 2.5Aap Implantate AG20160—
+3K151468ARIX Wrist SystemJeil Medical Corporation20167—
+3K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+3K150675Dorsal Spanning PlateSkeletal Dynamics, LLC20151—
+3K143050VLP Mini-Mod Small Bone Plating System 1.5mm Plates and ScrewsSmith & Nephew, Inc.20148—
+3K141905Pro-Link Wedge SystemLife Spine201411—
+3K141383Acumed Hand Fracture SystemAcumed, LLC20146—
+3K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.2014322
+3K140617Pinit Small Bone Fusion SystemArthrosurface, Inc.20144—
+3K132876Arix Hand Locking SystemJeil Medical Corporation20130—
+3K131566Arix Hand SystemJeil Medical Corporation20138—
+3K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+3K130008Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous…I.T.S. GmbH201311
+3K122005Maxlock Extreme SystemOrthohelix Surgical Designs, Inc.201239—
+3K120015Osteomed Wrist Plating SystemOsteomed LP20122—