510(k) Report

Devices descending from K061211

25 later devices reach NCB Plating System, Proximal Tibia Plates 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—
+1K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+1K151701Tenodesis screw systemNormed Medizin-Technik GmbH20160—
+1K101696Motionloc Screw for NCB Polyaxial Locking Plating SystemZimmer, Inc.201010—
+2K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+2K201259ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating SystemWrightmedicaltechnologyinc20210—
+2K142938G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20143—
+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—
+2K1105923.7MM/5.0MM Dynamic Locking ScrewSynthes USA201102
+3K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+3K233017TM Plating SystemTyber Medical, LLC20231—
+3K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+3K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+3K160633G3(TM) Active Plate (R) Small Fragment SystemGenesis Fracture Care, Inc.20160—
+3K152242G3¿ Active Plate® Large Fragment SystemGenesis Fracture Care, Inc.20151—
+3K143002Metallic Locking Bone Plate and Screw SystemChangzhou Dingjian Medical Appliance Co., Ltd.20151—
+3K150649G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20152—
+4K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+4K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+4K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+4K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+4K190842Comus Locking Plate systemsJiangsu Trauhui Medical Instrument Co., Ltd.20200—