510(k) Report

Devices descending from K962616

1,063 later devices reach Synthes Dorsal Distal Radius Plate (DDRP) System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K243408TACTIX Vector Syndesmosis SystemVilex, LLC20240—
+7K241995HyperFlex™ Bunion Correction SystemFootbridge Medical20241—
+7K242998GMReis Ankle Plating SystemGM Dos Reis Industria e Comercio Ltda.20241—
+7K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+7K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+7K230546SignexOsteonic Co., Ltd.20242—
+7K233531OIC FLEX-FIX™ SystemOrthopaedic Implant Company20240—
+7K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+7K232886INFILOOP® Fixed Loop UHMWPE Suture Titanium ButtonHealthium Medtech Limited20230—
+7K232755Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20232—
+7K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+7K231857Arthrex TightRope IIArthrex, Inc.20234—
+7K230938ARIX Humerus SystemJeil Medical Corporation20230—
+7K230204ALPHALOK Plating SystemVilex, LLC20230—
+7K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20232—
+7K222971ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device…Smith & Nephew, Inc.20230—
+7K213018Auxilock GFS Mini, GFS II Large, and GFS UltimateAuxein Medical Private Limited20220—
+7K221558ALPHALOK Plating SystemVilex, LLC20222—
+7K222244Arthrex 3.5 mm Locking Compression PlatesArthrex, Inc.20221—
+7K221485Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20225—
+7K220757Argo Knotless SP AnchorConmed Corporation20226—
+7K213837Arthrx Fracture PlatesArthrex, Inc.20220—
+7K201229Intai Anatomic Locking Plate and Screw SystemIntai Technology Corporation20220—
+7K212739ActiFlipParcus Medical, LLC20210—
+7K211049Tigon Medical Button SystemTigon Medical20210—
+7K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+7K210750Acumed Clavicle Hook Plating SystemAcumed, LLC20210—
+7K202444Knotless TensionTight Button Implant SystemArthrex, Inc.20201—
+7K202912ARIX Ankle Distal Tibia SystemJeil Medical Corporation20201—
+7K202935Syntec Femoral Nail Extended SystemSyntec Scientific Corporation20200—
+7K201083Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture AnchorsParcus Medical, LLC20203—
+7K200226RetroFixRetrofix Screws, LLC20200—
+7K200124InCore MPJ SystemNextremity Solutions, Inc.20200—
+7K200028Coronet Soft Tissue Fixation SystemConextions Medical20202—
+7K193165MectaFix CL Fixation Button with Continuous LoopMedacta International S.A.20200—
+7K192984APTUS Clavicle SystemMedartis AG20206—
+7K193606Y-Knot OneStep AnchorConmed Corporation20200—
+7K192578InCore TMT SystemNextremity Solutions, Inc.20191—
+7K191426FiberTak ButtonArthrex, Inc.20190—
+7K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc.201921
+7K190143LARS AC Band DeviceCorin USA20191—
+7K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—
+7K190288Arthrex Tenodesis ButtonArthrex, Inc.20194—
+7K191617Syntec Tibial Nail SystemSyntec Scientific Corporation20190—
+7K190774RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL ImplantMedos International SARL20191—
+7K191204Infinity Fixation SystemConmed Corporation20190—
+7K190231InCore® Lapidus Sterile KitsNextremity Solutions, Inc.20190—
+7K183094CyclaPlex Correction SystemCycla Orthopedics, Ltd.20190—
+7K181076Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20192—
+7K182621CrossFT Knotless Deep Thread Suture Anchor with Disposable DriverConmed Corporation20190—
+7K180951Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20194—
+7K173710MotoBAND CP Implant SystemCrossroads Extremity Systems, LLC201841
+7K173278ToggleLoc SystemBiomet, Inc.20183—
+7K171725CuffLink Implant SystemConmed Corporation20170—
+7K171592CrossFT™ Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation20171—
+7K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC2017151
+7K161665VLP Wrist Fracture SystemSmith & Nephew, Inc.201610—
+7K162307OrthoPediatrics Locking Proximal Femur System Cortical ScrewsOrthoPediatrics Corp.20161—
+7K160264Additive Orthopaedics Hammertoe Correction SystemAdditive Orthopaedics, LLC20164—
+7K160300MotoBand (TM) CP Implant SystemCrossroads Extremity Systems, LLC20166—
+7K160500Elite SPK, Compasso, Elite SPK KitNcs Lab Srl20160—
+7K151004PULLUP® Adjustable Juxtacortical Fixation DeviceSbm Sciences For Bio Materials20152—
+7K150768JuggerKnot Soft AnchorsBiomet Manufacturing Corp201540—
+7K151732Arthrex Fracture PlatesArthrex, Inc.201521—
+7K151068SureLock W Suture AnchorCayenne Medical, Inc.20156—
+7K151037GraftMax Button, ALB with Cradle, GraftMax Button, BTB with CradleConmed Corporation20155—
+7K141493Proximal Humerus Plating SystemMiami Device Solutions201571
+7K143172ACL SMART SystemSmith & Nephew, Inc.20150—
+7K141263Toggleloc and Juggerloc Implants/Instruments/KitsBiomet Manufacturing Corp201402
+7K141735Arthrex Ankle Fusion Plating SystemArthrex, Inc.2014381
+7K140431Pediloc Fragment SystemOrthoPediatrics Corp.20141—
+7K141677Variax Elbow Plating SystemStryker Trauma AG20140—
+7K141219Juggerloc Bone to Bone Implants/ Bone Instruments/ Bone Implant and Instrument KitsBiomet Manufacturing Corp20141—
+7K141478Arthrex Fracture Plates and ScrewsArthrex, Inc.2014231
+7K133579Multifilament Stainless Steel Sutures with CrimpsPontis Orthopaedics, LLC20140—
+7K140357Oic Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20142—
+7K133275Mini TightropeArthrex, Inc.201411—
+7K132296D-Rad Smart PackSmith & Nephew, Inc.2014114
+7K133224Y-Knot RC All-Suture Anchor, 2.8MM - Double Loaded and Triple Loaded W/ #2 Hifi SuturesConmed Corporation201412—
+7K131636Polarus ConnectAcumed, LLC20130—
+7K130814Rigidloop Fixation Device (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MMDepuy Mitek, A Johnson & Johnson Company20133—
+7K131620Jones-FX Fracture SystemInstratek, Inc.20131—
+7K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.201333—
+7K102689Conventus Orthopaedics Fracture Fixation SystemConventus Orthopaedics20134—
+7K122737Geminus Fossa Specific Plate SystemSkeletal Dynamics, LLC20123—
+7K111032CMC Cable FixInstratek, Inc.20112—
+7K111000Parcus 2.0MM / 2.5MM / 3.5MM Miti Titanium Suture AnchorParcus Medical, LLC20114—
+7K102597Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd.201115—
+7K101616The Grapplr and Grapplr ExtenderTag Medical Corp.20111—
+7K100325Peri-Loc Locking Hole Inserts and Cable AccessoriesSmith & Nephew, Inc.201038—
+7K091094Parcus V-Lox Peek CF Suture Anchor, Models: 10253, 10254, 10263, 10264Parcus Medical, LLC20097—
+7K090304Waveon WRX Bone Fixation SystemSonoma Orthopedic Products, Inc.20090—
+7K092015Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.2009411
+7K090923Parcus Graft Fixation SystemParcus Medical, LLC200921—
+7K083286Orthopediatrics Pediloc Locking Plate SystemOrthoPediatrics Corp.2009605
+7K083032Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc.2009772
+7K082516Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc.200887—
+7K081106Peri-Loc Periarticular Locked Plating System Volar Distal Radius Locking Plate for the…Smith & Nephew, Inc.200834—
+7K071563Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.2007495—
+7K061352Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc.2006108—