510(k) Report

Devices descending from K012655

792 later devices reach Congruent Bone Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+5K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc.20260—
+5K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…TriMed, Inc.20260—
+5K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+5K254215Arthrex Beaming SystemArthrex, Inc.20261—
+5K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+5K252246Leforte MMF SystemJeil Medical Corporation20260—
+5K253906Xpert HandNewclip Technics20260—
+5K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+5K254054VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating SystemSynthes GmbH20260—
+5K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+5K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG20251—
+5K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+5K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+5K243890Arthrex Intramedullary NailsArthrex, Inc.20250—
+5K242814Tandry Q-Locking Plate SystemMicroware Precision Co., Ltd.20240—
+5K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+5K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+5K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+5K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+5K241932OSSIOfiber® Compression StapleOSSIO, Ltd.20240—
+5K240318SITTER 3.5mm Versatile SystemBonebridge AG20244—
+5K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+5K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes20244—
+5K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+5K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+5K233302OSSIOfiber® Compression StapleOSSIO, Ltd.20231—
+5K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+5K230591TriLEAP Plating SystemCrossroads Extremity Systems20231—
+5K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+5K223150APS Metal Plate & Screw SystemA Plus Biotechnology Co., Ltd.20230—
+5K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+5K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+5K231333STRETTO™ Cable SystemGlobus Medical, Inc.20230—
+5K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+5K230053SimpliFix Hip SystemStabiliz Orthopaedics, Inc.20230—
+5K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+5K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+5K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+5K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+5K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+5K221342REDEMPTION Beaming SystemVilex, LLC20220—
+5K220839Arthrex Compression FT PinsArthrex, Inc.20220—
+5K221485Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20225—
+5K220892ExsoMed INnate NanoTM Lag Screw SystemExsomed Corp.20220—
+5K220181StealthFix Intraosseous Fixation SystemNextremity Solutions, Inc.20221—
+5K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+5K202326BESPA Charcot SystemBespa Global, LLC20210—
+5K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+5K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+5K210953SMART Taylor Spatial FrameSmith & Nephew, Inc.20212—
+5K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210—
+5K210994Arthrex Beveled FT ScrewsArthrex, Inc.20210—
+5K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+5K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed20210—
+5K200062Foot and Ankle SystemLeith Medical, LLC20210—
+5K203474Biomet Microfixation RibFix Advantage SystemBiomet Micofixation20213—
+5K202348External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc.20200—
+5K201253Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV…Smith & Nephew20205—
+5K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+5K202912ARIX Ankle Distal Tibia SystemJeil Medical Corporation20201—
+5K202935Syntec Femoral Nail Extended SystemSyntec Scientific Corporation20200—
+5K200987LTJ Screws and WasherAzurmeds, Inc.20201—
+5K193368Smart Correction SystemWishbone Medical, Inc.202031
+5K201578DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20203—
+5K201677Arthrex Mesh PlatesArthrex, Inc.20202—
+5K201556Intraosseous Fixation SystemExtremity Medical, LLC20200—
+5K200226RetroFixRetrofix Screws, LLC20200—
+5K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+5K193617Precice® ScrewsNuvasive Specialized Orthopedics, Inc.20200—
+5K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+5K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+5K193029Conquest FNSmith & Nephew, Inc.202010—
+5K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+5K192592Axis Plating SystemExtremity Medical, LLC20190—
+5K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—
+5K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+5K191617Syntec Tibial Nail SystemSyntec Scientific Corporation20190—
+5K191342CrossRoads Screw SystemCrossroads Extemity Systems, LLC20190—
+5K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+5K190992OrthoPediatrics PediFoot Deformity Corrections SystemOrthoPediatrics Corp.20190—
+5K190750DePuy Synthes Plates and Screws PortfolioDePuy Synthes20190—
+5K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+5K190069SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Arrowhead De, LLC20193—
+5K190586Monster® Screw SystemParagon 28, Inc.201921—
+5K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+5K180539Deformity Analysis and Correction Software (DACS) and InstrumentationArrowhead Medical Device Technologies, LLC20184—
+5K172975DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20182—
+5K173710MotoBAND CP Implant SystemCrossroads Extremity Systems, LLC201841
+5K172785Conquest FNSmith & Nephew20178—
+5K172350AxSOS 3 TiStryker GmbH201717—
+5K173135VariAx 2 SystemStryker GmbH201713—
+5K171293G3™ Active Plate® Miniature SystemGenesis Fracture Care, Inc.20170—
+5K162171S4 Screw System™Subchondral Solutions20173—
+5K170547Arthrex Mesh Plate SystemArthrex, Inc.201715—
+5K170038FuzeFix Screw SystemFusion Orthopedics, LLC20171—
+5K162874Cannulated Screws NeoorthoNeoortho Produtos Ortopedicos S/A20170—
+5K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+5K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+5K170382Arthrex Compression ScrewsArthrex, Inc.20173—