510(k) Report

Devices descending from K963798

756 later devices reach Synthes Titanium Alloy Volar Distal Radius Plate (TI Alloy VDRP) System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+6K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+6K243368Montblanc Plate SystemMedifield Medical Co., Ltd.20250—
+6K250920Arthrex Spine Compression FT ScrewArthrex, Inc.20251—
+6K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+6K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+6K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+6K243195Arthrex SS VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20251—
+6K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+6K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+6K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+6K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+6K240487EVOS Patella PlatesSmith & Nephew20240—
+6K241592Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+6K240318SITTER 3.5mm Versatile SystemBonebridge AG20244—
+6K241018KLS Martin Orthopedic Implants - MR ConditionalKLS-Martin L.P.20241—
+6K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+6K233919VariAx 2 Distal Radius SystemStryker GmbH20242—
+6K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+6K233017TM Plating SystemTyber Medical, LLC20231—
+6K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+6K230257Arthrex Intramedullary NailsArthrex, Inc.20231—
+6K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+6K213123EVOS Wrist Spanning PlateSmith & Nephew, Inc.20220—
+6K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+6K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+6K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+6K212348ALPHALOK™ Plating SystemVilex, LLC20223—
+6K220244DVR® Crosslock Wrist Spanning Plate (131849181)Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech20220—
+6K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+6K210994Arthrex Beveled FT ScrewsArthrex, Inc.20210—
+6K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+6K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+6K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+6K192417ARIX Cannulated Screw SystemJeil Medical Corporation20191—
+6K182785LOQTEQ VA Foot Plates 2.5Aap Implantate AG20190—
+6K181296Syntec Femoral Nail SystemSyntec Scientific Corporation20192—
+6K171372Alians Elbow Locking Plating SystemNewclip Technics20180—
+6K172008ARIX Humerus SystemJeil Medical Corporation20173—
+6K173135VariAx 2 SystemStryker GmbH201713—
+6K171285ARIX Diaphysis SystemJeil Medical Corporation20176—
+6K170687Flower Bone Screw SetFlower Orthopedics Corporation20170—
+6K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—
+6K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+6K161746ARIX Hand SystemJeil Medical Corporation20161—
+6K161539Arthrosurface Bone ScrewsArthrosurface, Inc.20162—
+6K161041OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20160—
+6K152306MotoBand¿ CP Implant SystemCrossroads Extremity Systems, LLC20157—
+6K142306Flower Upper Extremity Plating SetFlower Orthopedics Corporation20140—
+6K141301Maxlock Extreme Elbow Fracture SystemOrthohelix Surgical Designs, Inc.20140—
+6K133939Modified Distal Radius Plating SystemBiomet2014112
+6K140259Variax Clavicle Hook PlateStryker Trauma AG201413—
+6K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+6K132248Flower Bone Screw SetFlower Orthopedics Corporation20131—
+6K130116Superior Lateral Variax Clavicle PlateStryker Trauma AG201316—
+6K111086Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp.201171
+6K093868I.T.S. LRS Locking Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH201011
+6K101056Variax Elbow SystemHowmedica Osteonics Corp.201058—
+6K093433Variax Elbow System Plate Line ExtensionHowmedica Osteonics Corp.20101—
+6K092671Variax Elbow System Line ExtensionHowmedica Osteonics Corp.20090—
+6K090374Sterile DVR Anatomic Plates Various Configurations) Model (S) 131212001,2, 5-10 2.5MM…DePuy Orthopaedics, Inc.200918—
+6K082078Zimmer Periarticular Locking Plate System: Distal Humeral and Proximal Ulna PlatesZimmer, Inc.200847
+6K071809Ensplintrx Bone Fixation SystemSonoma Orthopedic Products, Inc.20086—
+6K060864Multidirectional Threaded PegHand Innovations, LLC200618—
+6K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc.2005584—
+7K262975Arthrex Beaming SystemArthrex, Inc.20260—
+7K262618Arthrex Spine Compression FT ScrewArthrex, Inc.20260—
+7K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+7K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+7K260810Anteralign LS coverplateTyber Medical, LLC20260—
+7K250988KLS Martin Pure Pectus SystemKLS-Martin L.P.20250—
+7K243890Arthrex Intramedullary NailsArthrex, Inc.20250—
+7K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+7K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+7K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+7K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+7K230938ARIX Humerus SystemJeil Medical Corporation20230—
+7K230204ALPHALOK Plating SystemVilex, LLC20230—
+7K221558ALPHALOK Plating SystemVilex, LLC20222—
+7K201229Intai Anatomic Locking Plate and Screw SystemIntai Technology Corporation20220—
+7K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+7K210750Acumed Clavicle Hook Plating SystemAcumed, LLC20210—
+7K202912ARIX Ankle Distal Tibia SystemJeil Medical Corporation20201—
+7K202935Syntec Femoral Nail Extended SystemSyntec Scientific Corporation20200—
+7K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc.201921
+7K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—
+7K191617Syntec Tibial Nail SystemSyntec Scientific Corporation20190—
+7K173710MotoBAND CP Implant SystemCrossroads Extremity Systems, LLC201841
+7K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+7K161665VLP Wrist Fracture SystemSmith & Nephew, Inc.201610—
+7K162307OrthoPediatrics Locking Proximal Femur System Cortical ScrewsOrthoPediatrics Corp.20161—
+7K160300MotoBand (TM) CP Implant SystemCrossroads Extremity Systems, LLC20166—
+7K141493Proximal Humerus Plating SystemMiami Device Solutions201571
+7K140431Pediloc Fragment SystemOrthoPediatrics Corp.20141—
+7K141677Variax Elbow Plating SystemStryker Trauma AG20140—
+7K140357Oic Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20142—
+7K132296D-Rad Smart PackSmith & Nephew, Inc.2014114
+7K131636Polarus ConnectAcumed, LLC20130—
+7K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.201333—
+7K102689Conventus Orthopaedics Fracture Fixation SystemConventus Orthopaedics20134—