510(k) Report

Devices descending from K042695

68 later devices reach NCB Plating System through their predicates, nearest generation first.

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