510(k) Report

Devices descending from K011815

185 later devices reach Synthes LCP Proximal Humerus Plates through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+3K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+3K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+3K201259ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating SystemWrightmedicaltechnologyinc20210—
+3K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+3K191118Avanti Distal Radius and Forearm SystemAvanti Orthopaedics, Inc.20191—
+3K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+3K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—
+3K171606AOS Anterolateral Proximal Humeral PlateAdvanced Orthopaedic Solutions, Inc. (Aos)20170—
+3K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+3K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc.20160—
+3K153379AxSOS 3TiStryker GmbH201625—
+3K151701Tenodesis screw systemNormed Medizin-Technik GmbH20160—
+3K152242G3¿ Active Plate® Large Fragment SystemGenesis Fracture Care, Inc.20151—
+3K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+3K150675Dorsal Spanning PlateSkeletal Dynamics, LLC20151—
+3K150649G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20152—
+3K141493Proximal Humerus Plating SystemMiami Device Solutions201571
+3K143050VLP Mini-Mod Small Bone Plating System 1.5mm Plates and ScrewsSmith & Nephew, Inc.20148—
+3K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.2014322
+3K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+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
+3K110271Maestro Wrist Plating SystemBiomet Manufacturing Corp20110—
+4K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+4K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG20260—
+4K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+4K261038Xpert PFPNewclip Technics20260—
+4K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+4K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+4K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+4K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+4K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+4K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+4K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+4K240487EVOS Patella PlatesSmith & Nephew20240—
+4K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+4K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+4K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+4K213123EVOS Wrist Spanning PlateSmith & Nephew, Inc.20220—
+4K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+4K212601DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company20220—
+4K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+4K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma20211—
+4K201728Versalock Periprosthetic Femur Plates System-GMReisGM Dos Reis Industria e Comercio Ltda.20210—
+4K172350AxSOS 3 TiStryker GmbH201717—
+4K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+4K163003Y3 Proximal Femoral Plate SystemPega Medical, Inc.20170—
+4K162439AxSOS 3 Ti; Stryker Plating SystemStryker GmbH201724—
+4K161292Distal Radius Plating SystemMiami Device Solutions, LLC20164—
+4K161058Cannulated ScrewMiami Device Solutions, LLC20161—
+4K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+4K143002Metallic Locking Bone Plate and Screw SystemChangzhou Dingjian Medical Appliance Co., Ltd.20151—
+5K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+5K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+5K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+5K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+5K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+5K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+5K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+5K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+5K233919VariAx 2 Distal Radius SystemStryker GmbH20242—
+5K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies20230—
+5K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+5K190842Comus Locking Plate systemsJiangsu Trauhui Medical Instrument Co., Ltd.20200—
+5K182810Distal Radius Plating SystemMiami Device Solutions, LLC20180—
+5K181091AxSOS 3 TiStryker GmbH201811—
+5K173556Injection ScrewBiedermann Medtech, Inc.20180—
+5K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+5K162898Olecranon Plating SystemMiami Device Solutions, LLC20171—
+5K162635Distal Radius Plating SystemMiami Device Solutions, LLC20162—
+5K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+6K242436Proximal Humerus Fixation SystemSkeletal Dynamics, Inc.20240—
+6K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+6K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+6K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+6K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+6K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+7K260810Anteralign LS coverplateTyber Medical, LLC20260—
+7K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+7K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—