510(k) Report

Devices descending from K914406

66 later devices reach PT II Distal Cement Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220838Artisan Bone Plug, Universal Cement RestrictorHowmedica Osteonics, Dba Stryker Orthopaedics20225—
+1K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics2016171
+1K992462Osteonics Universal Distal Cement PlugHowmedica Osteonics Corp.19990—
+1K990345Rabea Device, Model PxxxxxxSignus Medizintechnik GmbH199946—
+2K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+2K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+2K222632UHR Bipolar Implants, Restoration GAP II ImplantsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+2K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+2K210893Restoration Anatomic ShellHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20215—
+2K193429Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp.202061
+2K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20197—
+2K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics201882
+2K021788NBD Cement Restrictor DeviceNew Business Development, LLC20020—
+2K021719Fortitude Cement RestrictorSpinal Concepts, Inc.20026—
+2K020836Rabea Cement RestrictorSignus Medical, LLC20024—
+2K020344RPX Titanium Cemnt RestrictorSulzer Spine-Tech200233—
+2K012462Theken Large Cement RestrictorTheken Surgical,Llc20010—
+2K012278Theken Small Cement RestrictorTheken Surgical,Llc20010—
+3K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+3K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+3K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+3K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+3K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+3K23372428mm/38D MDM X3 Insert for MDM LinerHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+3K213701Exeter® X3® RimFit® CupHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+3K191414EXETER Centralizer, EXETER 2.5mm PlugStryker Orthopaedics20195—
+3K060132Spinal Usa Cement Restrictor SystemSpinal USA20060—
+3K051371Interbody Innovations Cement RestrictorInterbody Innovations, Llp20050—
+3K051607Novaspine Cement Restrictor NSCRNovaspine, LLC20050—
+3K052367Scient'x Cement RestrictorScient'X20051—
+3K041583Peek Cement Restrictor X-BoxInnovasis, Inc.20040—
+3K033953Optimesh 500E Cement RestrictorSpineology, Inc.20040—
+3K031837Modification to Fortitude Cement RestrictorSpinal Concepts, Inc.20035—
+3K022615Centerpulse, Spine-Tech Division Cement RestrictorCenterpulse Spine-Tech, Inc.200232—
+4K091425Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd.201031—
+5K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+5K131636Polarus ConnectAcumed, LLC20130—
+5K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+5K111056Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.2011151
+5K102597Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd.201115—
+5K102369Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd.2011161
+5K100497Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd.201029—
+6K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+6K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+6K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+6K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+6K160995NEOVIEW Plating SystemIn2bones Sas201624
+6K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+6K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+6K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+6K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd.201314—
+6K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+6K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+7K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+7K191118Avanti Distal Radius and Forearm SystemAvanti Orthopaedics, Inc.20191—
+7K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+7K163589SIGN IM NailSign Fracture Care International20170—
+8K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+8K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+8K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+8K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+9K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+9K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+9K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+10K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+10K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123