510(k) Report

Devices descending from K012114

205 later devices reach Synthes Locking Distal Radius Plating System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K254162KLS Martin Ixos SystemKLS Martin L.P.20260—
+4K252807Arthrex Anatomic Lapidus Plates and I-Beam Lapidus PlatesArthrex, Inc.20260—
+4K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+4K243368Montblanc Plate SystemMedifield Medical Co., Ltd.20250—
+4K250920Arthrex Spine Compression FT ScrewArthrex, Inc.20251—
+4K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—
+4K243761A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics20250—
+4K243195Arthrex SS VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20251—
+4K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+4K241592Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+4K241539Activmotion SNewclip Technics20240—
+4K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+4K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+4K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+4K220244DVR® Crosslock Wrist Spanning Plate (131849181)Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech20220—
+4K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+4K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+4K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+4K210994Arthrex Beveled FT ScrewsArthrex, Inc.20210—
+4K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+4K182785LOQTEQ VA Foot Plates 2.5Aap Implantate AG20190—
+4K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+4K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+4K170972Apex Tibial Nailing SystemOrthoxel20171—
+4K161327Syntec Humeral Nail SystemSyntec Scientific Corporation20173—
+4K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+4K142579Zimmer Periarticular Plating SystemZimmer, Inc.201402
+4K141228Aos 6.5MM Captured, Fully Threaded Cancellous ScrewAdvanced Orthopaedic Solutions, Inc.20142—
+4K140769Variax 2 SystemStryker Trauma AG201419—
+4K131657Flower Small and Medium Implant SetFlower Orthopedics Corporation2013111
+4K123562Flower Small and Medium Bone ImplantsFlower Orthopedics Corporation2013142
+4K113760Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks…Howmedica Osteonics Corp., Dba Stryker Orthopaedics201240—
+4K103408Posterior Lateral PlatesDePuy Orthopaedics, Inc.20103—
+4K070906Modificaton to: Zimmer Periarticular Locking Plates and ScrewsZimmer, Inc.20071421
+5K262975Arthrex Beaming SystemArthrex, Inc.20260—
+5K262618Arthrex Spine Compression FT ScrewArthrex, Inc.20260—
+5K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+5K252025Active Intramedullary (AIM) Tibial Nail SystemSatori Orthopaedics, Inc.20260—
+5K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+5K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+5K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+5K233919VariAx 2 Distal Radius SystemStryker GmbH20242—
+5K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+5K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+5K230257Arthrex Intramedullary NailsArthrex, Inc.20231—
+5K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+5K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+5K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+5K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+5K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+5K181296Syntec Femoral Nail SystemSyntec Scientific Corporation20192—
+5K171372Alians Elbow Locking Plating SystemNewclip Technics20180—
+5K173135VariAx 2 SystemStryker GmbH201713—
+5K170687Flower Bone Screw SetFlower Orthopedics Corporation20170—
+5K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+5K152306MotoBand¿ CP Implant SystemCrossroads Extremity Systems, LLC20157—
+5K142306Flower Upper Extremity Plating SetFlower Orthopedics Corporation20140—
+5K140259Variax Clavicle Hook PlateStryker Trauma AG201413—
+5K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+5K132248Flower Bone Screw SetFlower Orthopedics Corporation20131—
+5K130116Superior Lateral Variax Clavicle PlateStryker Trauma AG201316—
+5K111086Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp.201171
+5K093868I.T.S. LRS Locking Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH201011
+5K082078Zimmer Periarticular Locking Plate System: Distal Humeral and Proximal Ulna PlatesZimmer, Inc.200847
+6K260810Anteralign LS coverplateTyber Medical, LLC20260—
+6K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+6K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+6K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+6K243890Arthrex Intramedullary NailsArthrex, Inc.20250—
+6K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+6K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+6K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+6K233017TM Plating SystemTyber Medical, LLC20231—
+6K201229Intai Anatomic Locking Plate and Screw SystemIntai Technology Corporation20220—
+6K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+6K210750Acumed Clavicle Hook Plating SystemAcumed, LLC20210—
+6K202935Syntec Femoral Nail Extended SystemSyntec Scientific Corporation20200—
+6K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc.201921
+6K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—
+6K191617Syntec Tibial Nail SystemSyntec Scientific Corporation20190—
+6K180500VariAx 2 SystemStryker GmbH201812—
+6K173710MotoBAND CP Implant SystemCrossroads Extremity Systems, LLC201841
+6K162307OrthoPediatrics Locking Proximal Femur System Cortical ScrewsOrthoPediatrics Corp.20161—
+6K160300MotoBand (TM) CP Implant SystemCrossroads Extremity Systems, LLC20166—
+6K140431Pediloc Fragment SystemOrthoPediatrics Corp.20141—
+6K130008Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous…I.T.S. GmbH201311
+7K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+7K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+7K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+7K233089NeoSpan® Compression Implant SystemIn2bones USA, LLC20240—
+7K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+7K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+7K223342MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™…Crossroads Extremity Systems, LLC20232—
+7K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+7K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+7K202348External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc.20200—
+7K193617Precice® ScrewsNuvasive Specialized Orthopedics, Inc.20200—
+7K193452MotoBAND CP Implant SystemCrossroads Extemity Systems, LLC20203—
+7K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+8K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—