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
+4K160633G3(TM) Active Plate (R) Small Fragment SystemGenesis Fracture Care, Inc.20160—
+4K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+4K142906APTUS Wrist 2.5 SystemMedartis AG201559—
+4K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+4K150649G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20152—
+4K142502Alians Ulna Locking Plating SystemNewclip Technics20142—
+4K141734Zimmer Periarticular Locking SystemZimmer, Inc.201403
+4K141232Aptus Ulna Shortening 2.5Medartis AG201451
+4K133974Variax Distal Radius Plating SystemStryker Leibinger GmbH201420—
+4K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH201410—
+4K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc.2014462
+4K132769Acumed Hand Plating SystemAcumed, LLC20147—
+4K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—
+4K132502Variax 2 SystemStryker Trauma AG201321—
+4K130810Zimmer Motionloc Screw for Periarticular Locking Plate SystemZimmer, Inc.20131—
+4K131474Arthrex Distal Radius Plate SystemArthrex, Inc.201320—
+4K123672Inion Freedomscrew (Alternative Marketing Name: Inion Otps Freedomscrew)Inion OY201317—
+4K120015Osteomed Wrist Plating SystemOsteomed LP20122—
+4K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc.2012117
+4K112169Aptus Wrist Arthrodesis PlatesMedartis AG20128—
+4K111447Zimmer Periarticular ScrewsZimmer, Inc.201114
+4K112455Aiming Blocks for Variax Distal Radius PlatesHowmedica Osteonics Corp., Dba Stryker Orthopaedics201156—
+4K101930Memometal Navis Bone Plating SystemMemometal Technologies20110—
+4K103332Aptus Ulna PlatesMedartis AG201171—
+4K102537Aptus 1.5 TrilockMedartis AG201019—
+4K081392Bioretec Activascrew, Activascrew Cannulated and Activascrew Cannulated with ActivapinBioretec, Ltd.20082—
+4K0724234.5MM Locking Broad & Narrow Compression Plates, 4.5MM & 5.5MM Cortical & Cancellous…DePuy Orthopaedics, Inc.20074—
+4K062980ActivascrewBioretec, Ltd.20061—
+4K062498Profyle SystemHowmedica Osteonics Corp.2006811
+4K062617Modification to Inion Otps Biodegradable Fixation SystemInion, Ltd.20063—
+4K061917Distal Radius Locking Plating SystemNewclip Technics20066—
+4K053561Bio-Mini Revo Suture AnchorConmed Linvatec200675—
+4K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Arthrex, Inc.2005306—
+4K050121Zimmer Periarticular Locking Plate System, Model 2357 & 2359Zimmer, Inc.200527—
+4K042966Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models BXS4218…Linvatec Biomaterials, Ltd.200476—
+4K032705Distal Radius Fracture Repair SystemHand Innovations, Inc.2003615—
+5K261057ActivaScrew™ Cannulated COMBioretec, Ltd.20260—
+5K260761APTUS Clavicle System 2.8Medartis AG20260—
+5K252081SportLinc Syndesmosis DeviceLincotek Medical20260—
+5K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+5K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc.20260—
+5K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+5K253727Syndesmosis TightRope PROArthrex, Inc.20250—
+5K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+5K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG20251—
+5K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—
+5K243761A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics20250—
+5K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+5K241695Extremity All Suture SystemField Orthopaedics20240—
+5K232941Megaloop Button SystemSuzhou Endophix Co., Ltd.20240—
+5K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+5K234062APTUS Hand Scaphoid PlatesMedartis AG20243—
+5K233198OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd.20242—
+5K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+5K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+5K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Bonebridge AG20237—
+5K222624KLS Martin LINOS Wrist SystemKLS-Martin L.P.20235—
+5K223853Medartis APTUS® Ulna PlatesMedartis AG20235—
+5K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+5K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+5K222267Arthrex 2.4 mm Volar Distal Radius Plate SystemArthrex, Inc.20221—
+5K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+5K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+5K220260Hercules Syndesmosis Implant SystemIn2bones USA, LLC20220—
+5K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+5K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+5K212990Acumed Ankle Syndesmosis Repair SystemAcumed, LLC20220—
+5K211592Avanti Orthopaedics Ulnar Shortening SystemAvanti Orthopaedics, Inc.20211—
+5K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+5K203121Responsive Arthroscopy Thunderbolt SystemResponsive Arthroscopy, LLC20211—
+5K203105Inion CompressOn ScrewInion OY20210—
+5K200291CREED™ Cannulated ScrewsGlw Medical, Inc.20202—
+5K200332EXPERT - Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda.20201—
+5K201962Skeletal Dynamics Ulnar Shortening Plating SystemSkeletal Dynamics, Inc.20200—
+5K201656ARIX Elbow SystemJeil Medical Corporation20200—
+5K201522Arthrex Syndesmosis TightRope XP Buttress Plate Implant SystemArthrex, Inc.20207—
+5K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.20206—
+5K201132Arthrex Compression ScrewsArthrex, Inc.202011—
+5K193554APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 SystemMedartis AG20208—
+5K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+5K192297APTUS Wrist Arthrodesis PlatesMedartis AG20197—
+5K191783Parcus Synd-EZ TiParcus Medical, LLC20195—
+5K191848APTUS Wrist Spanning Plates 2.5Medartis AG20192—
+5K191319Dunamis Fixation Button SystemDunamis, LLC20191—
+5K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+5K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+5K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+5K173910Impress SFS SystemCable Fix Medical, LLC20180—
+5K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—
+5K180500VariAx 2 SystemStryker GmbH201812—
+5K171703PUMA SystemPanther Orthopedics, Inc.20180—
+5K170972Apex Tibial Nailing SystemOrthoxel20171—
+5K173550Akros FibuLink™ Syndesmosis Repair KitAkros Medical20174—
+5K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+5K172620SyndesMetrics Syndesmosis Repair SystemMortise Medical, LLC20170—
+5K170249GRAVITY™ Syndesmosis LPWrightmedicaltechnologyinc20172—
+5K161327Syntec Humeral Nail SystemSyntec Scientific Corporation20173—
+5K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+5K161861APTUS® Coronoid 2.0Medartis AG20170—
+5K162805Akros Fibulink Syndesmosis Repair KitAkros Medical20175—