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
+7K060156Straight Plate with Angular Stability & Screw SystemI.T.S. Implantat-Technologie-Systeme GmbH2006272
+7K060041Trimed Bone PlatesTriMed, Inc.2006263
+8K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.20260—
+8K261511Xpert AnkleNewclip Technics20260—
+8K254182AsterOsteonic Co., Ltd.20260—
+8K252997HyperFlex® Bunion Correction SystemHyperflex Medical20250—
+8K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda.20250—
+8K251310OTS 25-L (100-5)Ots Medical, Ltd.20250—
+8K251296The Acumed Wrist Fixation SystemAcumed, LLC202501
+8K251530CONMED Argo Knotless® AnchorConmed Corporation20250—
+8K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+8K250844PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip…Science & Bio Materials (S.B.M.) Sas20250—
+8K242973CanMINI Hand and Foot SystemCanwell Medical Co., Ltd.20250—
+8K243987TriMed Elbow and Forearm SystemTriMed, Inc.20251—
+8K243999TriMed Ankle Fixation SystemTriMed, Inc.20252—
+8K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+8K243344Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage…Arthrex, Inc.20250—
+8K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.20250—
+8K243726Osprey Suture AnchorResponsive Arthroscopy, Inc.20250—
+8K241234OTS 25-L (100-5)Ots Medical, Ltd.20251—
+8K242079Arthrex Elbow Fracture Plating SystemArthrex, Inc.20240—
+8K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+8K241235Arthrex TightRope IIArthrex, Inc.20243—
+8K233089NeoSpan® Compression Implant SystemIn2bones USA, LLC20240—
+8K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+8K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20241—
+8K240090Argo Knotless GENESYS AnchorConmed Corporation20242—
+8K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+8K233429OTS 25 (100-1)Ots Medical, Ltd.20232—
+8K233258Shadow Knotless All-Suture AnchorsResponsive Arthroscopy, LLC20230—
+8K230976Arthrex Radiopaque FiberTape Cerclage suturesArthrex, Inc.20231—
+8K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC20231—
+8K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+8K230123Apollo Knotless Suture AnchorMaruho Medical20230—
+8K223342MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™…Crossroads Extremity Systems, LLC20232—
+8K220966SinefixBAAT Medical Products B.V.20231—
+8K223118OIC Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20231—
+8K222763Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsResponsive Arthroscopy, LLC20221—
+8K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+8K202663Suture WingOsteonic Co., Ltd.20211—
+8K203259FairFix Adjustable Button SystemMedacta International S.A.20213—
+8K203740JuggerKnot Soft AnchorRiverpoint Medical20215—
+8K203294Arthrex Pilon Fusion SystemArthrex, Inc.20212—
+8K203405EVOS Large Fragment Plating SystemSmith & Nephew, Inc.20213—
+8K203485SnugFit All-Suture AnchorMedacta International S.A.20212—
+8K202291Button LoopYunyi (Beijing) Medical Device Co., Ltd.20210—
+8K202348External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc.20200—
+8K192709Fixone All Suture AnchorAju Pharm Co., Ltd.20203—
+8K202307Activ FuseNewclip Technics20200—
+8K201918EVOS Large Fragment Plating SystemSmith & Nephew, Inc.202044
+8K202193PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP…S.B.M. Sas (Science & Bio Materials)20201—
+8K202153Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20201—
+8K201149CoLink Plating SystemIn2bones USA, LLC20200—
+8K200538Skeletal Dynamics Forearm Plating SystemSkeletal Dynamics, Inc.20201—
+8K193617Precice® ScrewsNuvasive Specialized Orthopedics, Inc.20200—
+8K193461MectaLock All-Suture AnchorsMedacta International S.A.20203—
+8K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+8K192750AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate HipParcus Medical, LLC20203—
+8K193452MotoBAND CP Implant SystemCrossroads Extemity Systems, LLC20203—
+8K190921Arthrex Low Profile ScrewsArthrex, Inc.20190—
+8K190953Arthrex Minimally Invasive Ankle Fusion PlateArthrex, Inc.20191—
+8K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+8K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+8K190926Hammertoe Truss System (HTS)4Web, Inc.20193—
+8K190728Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+8K190446Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20191—
+8K181843MLP Special Locking Bone Plate SystemMaxxion Medical, LLC / Baumer SA20190—
+8K182361Arthrex Compression FT ScrewsArthrex, Inc.20184—
+8K180768Arthrex SwiveLock AnchorsArthrex, Inc.201828—
+8K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+8K180763CuffLink Implant System BiocompositeConmed Corporation20180—
+8K180377Fracture and Correction SystemIn2bones USA, LLC20187—
+8K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+8K173293EVOS Small Fragment Upper Extremity PlatesSmith & Nephew, Inc.201812—
+8K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+8K172186BioWick X Implant with DriverCayenne Medical, Inc.20174—
+8K171465Stryker Self-Punching ICONIXStryker20171—
+8K170457EVOS Small Fragment Lower Extremity PlatesSmith & Nephew, Inc.2017131
+8K170887EVOS Small Fragment Plating SystemSmith & Nephew, Inc.201713—
+8K162078EVOS Small Fragment Plating SystemSmith & Nephew, Inc.2016261
+8K162198GFS UltimateParcus Medical, LLC20168—
+8K161292Distal Radius Plating SystemMiami Device Solutions, LLC20164—
+8K161048Conventus Orthopaedics Ulna Fixation SystemConventus Orthopaedics, Inc.20160—
+8K160995NEOVIEW Plating SystemIn2bones Sas201624
+8K153558Ventix Suture AnchorBiomet Manufacturing Corp20160—
+8K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+8K151735TriMed Humeral Supracondylar Fixation SystemTriMed, Inc.20160—
+8K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC201515—
+8K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+8K151379Conventus PRS SystemConventus Orthopaedics, Inc.20151—
+8K141737Conventus PHS SystemConventus Orthopaedics, Inc.20150—
+8K142653G-Lok and G-Lok XL ExtenderT.A.G. Medical Products Corporation, Ltd.20140—
+8K141430Variax Distal Radius Plating SystemStryker Leibinger GmbH & Co KG201412—
+8K141121Axsos 3 TI Locking Plate SystemStryker Trauma AG201426—
+8K140328CMC Mini TightropeArthrex, Inc.20146—
+8K131552Conventus DRSConventus Orthopaedics20142—
+8K133757GFS II Standard, GFS II Large, GFS MimiParcus Medical, LLC201416—
+8K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+8K122310Geminus Fossa Specific Plate SystemSkeletal Dynamics, LLC20130—
+8K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—