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
+5K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc.20160—
+5K160304OsteoBullet Compression ScrewPhalanx Innovations20168—
+5K151468ARIX Wrist SystemJeil Medical Corporation20167—
+5K152145OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20151—
+5K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+5K150359Tensyn PlugDallen Medical, Inc.20150—
+5K150456Arthrex Plates, Screws, and StaplesArthrex, Inc.20156—
+5K143749Arthrex Distal Radius SystemArthrex, Inc.20152—
+5K143050VLP Mini-Mod Small Bone Plating System 1.5mm Plates and ScrewsSmith & Nephew, Inc.20148—
+5K141228Aos 6.5MM Captured, Fully Threaded Cancellous ScrewAdvanced Orthopaedic Solutions, Inc.20142—
+5K141383Acumed Hand Fracture SystemAcumed, LLC20146—
+5K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.2014322
+5K140617Pinit Small Bone Fusion SystemArthrosurface, Inc.20144—
+5K140769Variax 2 SystemStryker Trauma AG201419—
+5K133858Tensyn BandDallen Medical, Inc.20143—
+5K132733Orthohelix Syndesmosis Fixation DevicesOrthohelix Surgical Designs, Inc.20143—
+5K132876Arix Hand Locking SystemJeil Medical Corporation20130—
+5K131850Tensyn BandDallen Medical, Inc.20135—
+5K131566Arix Hand SystemJeil Medical Corporation20138—
+5K130716Bioretec Activascrew InterferenceBioretec, Ltd.20130—
+5K131657Flower Small and Medium Implant SetFlower Orthopedics Corporation2013111
+5K130008Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous…I.T.S. GmbH201311
+5K123562Flower Small and Medium Bone ImplantsFlower Orthopedics Corporation2013142
+5K113760Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks…Howmedica Osteonics Corp., Dba Stryker Orthopaedics201240—
+5K111971Synde-Lock Syndesmosis Repair KitTarsus Medical, Inc.20120—
+5K112437Arthrex Fracture SystemArthrex, Inc.201191—
+5K112560Aptus (R) Distal Humerus SystemMedartis AG20118—
+5K111779Y-Knot All-Suture Anchor Model HF13Conmed Linvatec201129—
+5K103408Posterior Lateral PlatesDePuy Orthopaedics, Inc.20103—
+5K101100Crossft OC Suture Anchor Mode CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503Conmed Linvatec201052
+5K092898Conmed Linvatec Presto Preloaded with One or Two #2 HI-FI SuturesConmed Linvatec20090—
+5K091549Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp.2009561
+5K090835Conmed Linvatec Bio Mini-Revo Suture Anchor, Model C6170CRLinvatec Corp.200910—
+5K090186Conmed Linvatec Paladin, Preloaded with Two #2 HI-FI SuturesLinvatec Corp.20090—
+5K083070Toggleloc SystemBiomet Sports Medicine2008946
+5K082095Ultraslide Acromioclavicular and Syndesmotic Repair DeviceSmith & Nephew Endoscopy, Inc.200859—
+5K072291Conmed Linvatec Bio Mini-Revo Suture AnchorConmed Linvatec200825—
+5K073527Variax Elbow SystemHowmedica Osteonics Corp.200861—
+5K070906Modificaton to: Zimmer Periarticular Locking Plates and ScrewsZimmer, Inc.20071421
+5K061925Mini Tightrope Repair Kit, Model AR-8911DSArthrex, Inc.200633—
+5K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…Arthrex, Inc.2005217—
+5K050932Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc.20056061
+5K042437Dorsal Intramedullary PlateDeo Volente Orthopaedics, LLC20047—
+6K261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+6K261632Thunderbolt SystemResponsive Arthroscopy, Inc.20260—
+6K261363Y-Knotless™ Flex AnchorsCONMED Corporation20260—
+6K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+6K254215Arthrex Beaming SystemArthrex, Inc.20261—
+6K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+6K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+6K252196Arthrex FibuLock Nail SystemArthrex, Inc.20260—
+6K252025Active Intramedullary (AIM) Tibial Nail SystemSatori Orthopaedics, Inc.20260—
+6K254162KLS Martin Ixos SystemKLS Martin L.P.20260—
+6K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+6K252807Arthrex Anatomic Lapidus Plates and I-Beam Lapidus PlatesArthrex, Inc.20260—
+6K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+6K250865KLS Martin IPS Forearm SystemKLS-Martin L.P.20250—
+6K251643Synchfix EVTWright Medical Technology, Inc. (Stryker Corporation)20250—
+6K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+6K252657Impact PEEK Union Nail SystemNvision Biomedical Technologies, Inc.20250—
+6K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+6K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+6K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+6K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+6K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+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—
+6K242311EXPERT - Flexible Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda.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—
+6K240035TACTIX Vector Syndesmosis SystemVilex, LLC20241—
+6K241018KLS Martin Orthopedic Implants - MR ConditionalKLS-Martin L.P.20241—
+6K241277OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20241—
+6K240947TENSOR® Suture Button SystemGlobus Medical, Inc.20240—
+6K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+6K233919VariAx 2 Distal Radius SystemStryker GmbH20242—
+6K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+6K233017TM Plating SystemTyber Medical, LLC20231—
+6K232780CC-Clip® Implant SystemCc-Instruments, Inc.20230—
+6K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+6K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+6K230257Arthrex Intramedullary NailsArthrex, Inc.20231—
+6K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+6K222589Flexible Suturing System with Anchors (FSSA)Integrity Orthopaedics, Inc.20230—
+6K223847CREED™ Cannulated ScrewsGlw, Inc.20230—
+6K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd.20224—
+6K221489Artemis Proximal Femoral Nail SystemGlw, Inc.20220—
+6K213123EVOS Wrist Spanning PlateSmith & Nephew, Inc.20220—
+6K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+6K221502Parcus Synd-EZ SSParcus Medical, LLC20220—
+6K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—