510(k) Report

Devices descending from K011335

840 later devices reach Synths One-Third Tubular DCL Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K060041Trimed Bone PlatesTriMed, Inc.2006263
+3K052614Low Profile Plate and Screw SystemArthrex, Inc.2005245—
+3K050681Omnitech System & Easy Lock Osteosystem with Xtremities PlatesTriMed, Inc.200592—
+3K051162Generos SB Small Bone Distraction ImplantOrthonetx, Inc.20050—
+3K030881Avanta Carpal Fusion Plating SystemAvanta Orthopaedics, Inc.20030—
+4K254280F.A.S.T ScrewSteps Ortho20260—
+4K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+4K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+4K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+4K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+4K260761APTUS Clavicle System 2.8Medartis AG20260—
+4K254215Arthrex Beaming SystemArthrex, Inc.20261—
+4K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+4K252246Leforte MMF SystemJeil Medical Corporation20260—
+4K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+4K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+4K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+4K254162KLS Martin Ixos SystemKLS Martin L.P.20260—
+4K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+4K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+4K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+4K252356The Acumed Wrist Fixation System - 2.4mm ScrewsAcumed, LLC20250—
+4K252061Distal Xtremities SystemTriMed, Inc.20250—
+4K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+4K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+4K250920Arthrex Spine Compression FT ScrewArthrex, Inc.20251—
+4K243943TriMed® Compression ScrewsTriMed, Inc.20252—
+4K250948TriMed Fusion Cup SystemTriMed, Inc.20250—
+4K243987TriMed Elbow and Forearm SystemTriMed, Inc.20251—
+4K243195Arthrex SS VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20251—
+4K242079Arthrex Elbow Fracture Plating SystemArthrex, Inc.20240—
+4K240175Tigon Medical Fractures, Instability, and Reconstruction (FIRE)Tigon Medical20240—
+4K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+4K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+4K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+4K240487EVOS Patella PlatesSmith & Nephew20240—
+4K241592Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+4K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+4K242055Freefix Forearm Plating SystemSkeletal Dynamics, Inc.20240—
+4K241539Activmotion SNewclip Technics20240—
+4K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+4K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+4K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+4K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+4K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+4K230591TriLEAP Plating SystemCrossroads Extremity Systems20231—
+4K230053SimpliFix Hip SystemStabiliz Orthopaedics, Inc.20230—
+4K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+4K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+4K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+4K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+4K221342REDEMPTION Beaming SystemVilex, LLC20220—
+4K221412ARIX Rib SystemJeil Medical Corporation20221—
+4K220839Arthrex Compression FT PinsArthrex, Inc.20220—
+4K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+4K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+4K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+4K221362Omni Foot and Ankle Plating SystemExremity 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—
+4K213895Distal Humerus Plating SystemSkeletal Dynamics, Inc.20220—
+4K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+4K202326BESPA Charcot SystemBespa Global, LLC20210—
+4K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+4K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+4K210953SMART Taylor Spatial FrameSmith & Nephew, Inc.20212—
+4K210994Arthrex Beveled FT ScrewsArthrex, Inc.20210—
+4K203405EVOS Large Fragment Plating SystemSmith & Nephew, Inc.20213—
+4K201253Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV…Smith & Nephew20205—
+4K201918EVOS Large Fragment Plating SystemSmith & Nephew, Inc.202044
+4K202589APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS…Medartis AG202061
+4K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+4K200987LTJ Screws and WasherAzurmeds, Inc.20201—
+4K193368Smart Correction SystemWishbone Medical, Inc.202031
+4K201578DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20203—
+4K201556Intraosseous Fixation SystemExtremity Medical, LLC20200—
+4K201235Arthrex MaxForce MTP Compression Plates and ScrewsArthrex, Inc.20200—
+4K193639APTUS® Foot 2.8-3.5 SystemMedartis AG20209—
+4K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+4K193029Conquest FNSmith & Nephew, Inc.202010—
+4K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+4K191342CrossRoads Screw SystemCrossroads Extemity Systems, LLC20190—
+4K190992OrthoPediatrics PediFoot Deformity Corrections SystemOrthoPediatrics Corp.20190—
+4K190166TriMed Nitinol Staple SystemTriMed, Inc.20190—
+4K190069SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Arrowhead De, LLC20193—
+4K190586Monster® Screw SystemParagon 28, Inc.201921—
+4K182402CoLink View Plating SystemIn2bones USA, LLC20182—
+4K180539Deformity Analysis and Correction Software (DACS) and InstrumentationArrowhead Medical Device Technologies, LLC20184—
+4K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—
+4K172785Conquest FNSmith & Nephew20178—
+4K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+4K170972Apex Tibial Nailing SystemOrthoxel20171—
+4K172886Breakaway Screw SystemParagon 2820174—
+4K173135VariAx 2 SystemStryker GmbH201713—
+4K172300CoLink View Plating SystemIn2bones USA, LLC201716—
+4K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+4K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+4K170780ARIX Foot System (2.3/2.8)Jeil Medical Corporation20174—
+4K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—