510(k) Report

Devices descending from K003235

80 later devices reach PE.R.I. II Knee Fracture System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc.2012117
+1K060969Polyax Locked Plating SystemDePuy Orthopaedics, Inc.20061010
+1K042695NCB Plating SystemZimmer GmbH2004681
+2K243761A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics20250—
+2K241754NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable…Zimmer Switzerland Manufacturing GmbH20240—
+2K192217NCB Plating System Distal Femur and Proximal TibiaZimmer GmbH201911—
+2K192021NCB Polyaxial Locking Plate SystemZimmer GmbH20191—
+2K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+2K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+2K142938G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20143—
+2K121672Aft Proximal Humerus Fracture PlateShoulder Options, Inc.201220—
+2K101696Motionloc Screw for NCB Polyaxial Locking Plating SystemZimmer, Inc.201010—
+2K100111NCB Periprosthetic Femur Polyaxial Locking Plate SystemZimmer, Inc.2010182
+2K081759NCB Polyaxial Locking Plate System, Proximal Humeral Plates, Zimmer Universal Locking…Zimmer GmbH2008212
+2K0724234.5MM Locking Broad & Narrow Compression Plates, 4.5MM & 5.5MM Cortical & Cancellous…DePuy Orthopaedics, Inc.20074—
+2K061211NCB Plating System, Proximal Tibia PlatesZimmer GmbH2006254
+3K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+3K201259ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating SystemWrightmedicaltechnologyinc20210—
+3K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+3K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+3K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+3K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+3K160633G3(TM) Active Plate (R) Small Fragment SystemGenesis Fracture Care, Inc.20160—
+3K151701Tenodesis screw systemNormed Medizin-Technik GmbH20160—
+3K152242G3¿ Active Plate® Large Fragment SystemGenesis Fracture Care, Inc.20151—
+3K150649G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20152—
+3K141493Proximal Humerus Plating SystemMiami Device Solutions201571
+3K133668Aft Greater Tuberosity Fracture Plate, Left, Aft Greater Tuberosity Fracture Plate…Shoulder Options, Inc.201416—
+3K130810Zimmer Motionloc Screw for Periarticular Locking Plate SystemZimmer, Inc.20131—
+3K130731Stabiliz Fixation System - SPL Locking ScrewStabiliz Orthopaedics, LLC20130—
+3K123918Motionloc Screw for NCB Polyaxial Locking Plate SystemZimmer, Inc.20135—
+3K120772NCB Periprosthetic Trochanter Plates and Screws, NCB Cable Button for NCB Oplyaxial…Zimmer GmbH201262
+3K113718NCB Straight Narrow Shaft PlatesZimmer GmbH201271
+3K1105923.7MM/5.0MM Dynamic Locking ScrewSynthes USA201102
+3K103408Posterior Lateral PlatesDePuy Orthopaedics, Inc.20103—
+4K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+4K261038Xpert PFPNewclip Technics20260—
+4K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+4K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+4K233017TM Plating SystemTyber Medical, LLC20231—
+4K223933Exactech Equinoxe PHx Fracture System; Exactech EPIC ScrewsExactech, Inc.20230—
+4K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+4K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+4K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+4K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma20211—
+4K201728Versalock Periprosthetic Femur Plates System-GMReisGM Dos Reis Industria e Comercio Ltda.20210—
+4K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+4K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+4K171372Alians Elbow Locking Plating SystemNewclip Technics20180—
+4K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+4K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+4K163003Y3 Proximal Femoral Plate SystemPega Medical, Inc.20170—
+4K161292Distal Radius Plating SystemMiami Device Solutions, LLC20164—
+4K161058Cannulated ScrewMiami Device Solutions, LLC20161—
+4K143002Metallic Locking Bone Plate and Screw SystemChangzhou Dingjian Medical Appliance Co., Ltd.20151—
+5K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+5K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+5K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+5K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+5K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+5K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+5K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+5K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies20230—
+5K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+5K190842Comus Locking Plate systemsJiangsu Trauhui Medical Instrument Co., Ltd.20200—
+5K182810Distal Radius Plating SystemMiami Device Solutions, LLC20180—
+5K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+5K173556Injection ScrewBiedermann Medtech, Inc.20180—
+5K173746Activmotion RangeNewclip Technics20181—
+5K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+5K162898Olecranon Plating SystemMiami Device Solutions, LLC20171—
+5K162635Distal Radius Plating SystemMiami Device Solutions, LLC20162—
+6K241539Activmotion SNewclip Technics20240—
+6K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+6K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+6K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+7K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+7K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+8K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+8K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—