510(k) Report

Devices descending from K943589

731 later devices reach Stryker Total Performance System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143191IntelliSense DrillMcginley Innovations20151—
+1K053526Microspeed Uni Motor SystemAesculap, Inc.2006121
+1K012453Sodem High Speed System (Electric) (General Orthopedics & Plastic Surgery)Sodemsystems2001447—
+1K991696Stryker Hermes-Ready Total Performance SystemStryker Instruments1999253—
+1K981637Integrated Drive/Pump System for OtolaryngologyLinvatec Corp.1998478—
+2K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210—
+2K152960ELAN 4 Motor SystemAesculap, Inc.20163—
+2K132264PRIMADO2 Total Surgical SystemNakanishi, Inc.20136—
+2K081475Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power…Medtronic Xomed, Inc.20084433
+2K081277XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power CONS0LE (Ipc)Medtronic Xomed, Inc.20084201
+2K080444Conmed Linvatec Osprey Drill SystemConmed Linvatec20080—
+2K040270Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd.2004226—
+2K040369Stryker Consolidated Operating Room Equipment (Core) SystemStryker Instruments200478
+2K040300Stryker Consolidated Operating Room Equipment (Core)Stryker Instruments200478
+2K032303Stryker Consolidated Operating Room Equipment (Core) SystemStryker Instruments20041465
+2K032117Stryker Total Performance (TPS) SystemStryker Instruments2003238—
+2K022986The Bioplate Battery Powered DrillBioplate, Inc.20020—
+2K014060Microaire 1000E SystemMicroaire Surgical Instruments, Inc.20027—
+2K990524E9000 SystemLinvatec Corp.1999477—
+3K233958hekaDrillZethon, Ltd.20240—
+3K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+3K213221AMADEO, M-UK1015 (incl. attachments and accessories)W&H Dentalwerk Buermoss GmbH20221—
+3K202120P300 AttachmentNakanishi, Inc.20211—
+3K203739ELAN 4 Electro Motor SystemAesculap, Inc.20210—
+3K191479Velocity Alpha Highspeed Surgical Drill SystemAdeor Medical AG20210—
+3K193630hekaDrillZethon, Ltd.20210—
+3K172907ELAN 4 Air Motor SystemAesculap, Inc.201802
+3K170312IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw…Medtronic Powered Surgical Solutions201711—
+3K163565MR8 Drill SystemMedtronic Powered Surgical Solutions20177—
+3K161704Phasor DrillBiotex, Inc.201641
+3K160713Stealth-Midas SystemMedtronic Powered Surgical Solutions20169—
+3K150728XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV PoleMedtronic Xomed, Inc.20150—
+3K141122Harmonic Scallop Blade, Generator G11Ethicon Endo-Surgery, LLC20149—
+3K130755Hicut Highspeed InstrumentAdeor Medical AG20144—
+3K133061Espin SystemNlt Spine, Ltd.20130—
+3K121264Triton Electric High Torque Handpiece and Software ModuleMedtronic Surgical Technologies201212—
+3K111520Ipc Powerease SystemMedtronic Xomed, Inc.20114182
+3K092977Eberle Shaver System AccessoriesEfs Eberle Feinwerktechnische Systeme20101—
+3K083284Piezosurgery MedicalPiezosurgery S.R.L.20099—
+3K083161Zen Wireless Footswitch (W1000), Zen Wireless Footswitch Adapter (W1100)Conmed Linvatec20099—
+3K071859Stryker Crossfire SystemStryker Endoscopy200742
+3K061966Litetouch Dental Laser SystemLight Instrument, Ltd.20063—
+3K061134Eberle Shaver System C2 and Shaver BladesEfs Eberle Feinwerktechnische Systeme20062—
+3K060172Rema Shaver BladesRema Medizintechnik GmbH.20060—
+3K052695Suretek Medical Reprocessed Arthroscopic Blades and BursSuretek Medical20060—
+3K060033Profile Multi-Platform SystemSciton, Inc2006221—
+3K022942CraniocutAesculap, Inc.20020—
+3K012630Reprocessed Linvatec Arthroscopic BursAlliance Medical, Inc.20010—
+3K012613Reprocssed Linvatec ShaversAlliance Medical, Inc.200101
+3K012457Sodem High Speed System (Electric) (Neuro/Spine Surgery)Sodemsystems2001447—
+3K012456Sodem High Speed System (Electric) (Ear, Nose, and Throat)Sodemsystems2001446—
+4K254174Surgical Power SystemGuizhou Zirui Technology Co., Ltd.20260—
+4K252666Articulator Arthroscopic BurJoint Preservation Innovations, LLC20250—
+4K252696LegacyPhasor Health, LLC20250—
+4K252060GREENPhasor Health, LLC20250—
+4K252662UniBurNakanishi, Inc.20250—
+4K240340Surgical Drive System (Model: ES70, ES90, E8)Guangdong Jinme Medical Technology Co., Ltd.20240—
+4K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+4K232684Surgify HaloSurgify Medical OY20233—
+4K230619Hubly Electric Drill (H100)Hubly, Inc.20231—
+4K220241“POINT” Kinguide Robotic-Assisted Surgical SystemPoint Robotics MedTech, Inc.20224—
+4K213761Joule diVa SystemSciton, Inc20220—
+4K212614Ultrasonic Scalpel SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.20221—
+4K210637CD Horizon™ Spinal SystemMedtronic202134—
+4K193608EBERLE Shaver System C3 and AccessoriesEberle GmbH & Co. KG20210—
+4K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202054—
+4K191597Stealth Autoguide System, Midas Rex Legend Depth Stop SystemMedtronic Navigation, Inc.201941
+4K183644Stealth-Midas MR8 SystemMedtronic Powered Surgical Solutions20193—
+4K183515MR8 Drill System, Midas Rex MR8 ClearView ToolsMedtronic Powered Surgical Solutions20194—
+4K182436POWEREASE SystemMedtronic Sofamor Danek USA, Inc.20180—
+4K170073LightMed Dental Laser SystemLightmed Dentaltechnology Corp.20170—
+4K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…Medtronic Sofamor Danek201786—
+4K162770Relign SystemRelign Corporation20172—
+4K160554Enseal X1 Large Jaw Tissue SealerEthicon Endo-Surgery, LLC20166—
+4K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Medtronic Sofamor Danek201679—
+4K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+4K153463CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201587—
+4K143019CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201588—
+4K141975Waterlase Iplus SBiolase, Inc.20150—
+4K140454Navigated CD Horizon Solera Screwdriver/TapsMedtronic Sofamor Danek USA, Inc.20143961
+4K132848Piezosurgery FlexMectron S.P.A.20136—
+4K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+4K124004Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy TapsMedtronic Navigation, Inc.20134041
+4K123270Powerease SystemMedtronic Sofamor Danek USA, Inc.2013398—
+4K101916Joule Multi-Platform SystemSciton, Inc2011111—
+4K100638Vapr Vue Radiofrequency System ,Model 225024, VPR Vue Wireless Footswitch, Model 227214Depuy Mitek, A Johnson & Johnson Company20108—
+4K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+4K100410Piezoelectric SystemSatelec20108—
+4K073411LiteduoLight Instruments20081—
+4K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+4K070388Profile Multi-Platform SystemSciton, Inc2007129—
+4K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+4K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+5K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+5K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+5K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+5K253604TiLink-L Navigation InstrumentsSurGenTec, LLC20260—
+5K253444EUROPA™ Posterior Cervical Fusion Navigated InstrumentsMiRus, LLC20260—