510(k) Report

Devices descending from K943569

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+8K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+8K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+8K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+8K251943Spineology Navigation InstrumentsSpineology, Inc.20250—
+8K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+8K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+8K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+8K242859VEGAIbramed Equipamentos Médicos20250—
+8K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+8K241525ExcelsiusXR™Globus Medical, Inc.20250—
+8K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+8K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+8K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+8K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+8K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+8K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+8K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+8K243693NEO Pedicle Screw System™Neo Medical SA20240—
+8K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+8K242414TiLink-P Joint Fusion SystemSurGenTec, LLC20240—
+8K240160EGPS Navigated InstrumentsAstura Medical20240—
+8K242141TiLink-P SI Joint Fusion SystemSurGenTec, LLC20241—
+8K241656Eneka SelectifTermosalud20241—
+8K241600DermablateAsclepion Laser Technologies GmbH20240—
+8K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+8K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+8K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+8K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+8K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+8K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+8K234057NirvanaEl.En S.P.A.20240—
+8K240647Virage® Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20240—
+8K233024Alma HarmonyAlma Lasers, Inc.20241—
+8K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+8K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+8K232236EchoQuanta System Spa20230—
+8K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+8K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+8K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+8K231054V-LaserWontech Co., Ltd.20231—
+8K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+8K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+8K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+8K223558CUVIS-spineCurexo, Inc.20230—
+8K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+8K230989Rod Registration FrameNu Vasive, Incorporated20230—
+8K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+8K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+8K223540AvalancheLase FamilyFotona D.O.O.20230—
+8K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+8K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+8K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+8K213267Dynamis Pro FamilyFotona D.O.O.20222—
+8K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+8K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+8K221571InMode Multi-systemInMode, Ltd.20222—
+8K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+8K213350mJOULE System and AccessoriesSciton, Inc20220—
+8K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+8K202288FinebeamSNJ Co., Ltd.20212—
+8K212607DarwinLuvo Medical Technologies, Inc.20210—
+8K212692Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation202146—
+8K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+8K201569CUVIS-spineCurexo, Inc.20212—
+8K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+8K203788DermaV Laser SystemLutronic Corporation202101
+8K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+8K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+8K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+8K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+8K202172StarWalkerFotona D.O.O.20203—
+8K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+8K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+8K200896Solstice CCILife Spine, Inc.20200—
+8K192856MT OneM&T S.R.L.20202—
+8K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+8K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+8K191942MT One DiamondM&T S.R.L.20191—
+8K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+8K191575ARx Spinal SystemLife Spine, Inc.201910—
+8K183156V-LaserWontech Co., Ltd.20193—
+8K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+8K181518Sebacia MicroparticlesSebacia, Inc.20180—
+8K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+8K172413MT ONEM&T S.R.L.20175—
+8K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+8K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+8K161185LUCERNA Dental LaserViax Dental Lab20160—
+8K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+8K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+8K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+8K131839DC 7Dc International, LLC20130—
+8K130465EPIC 10SBiolase Technology, Inc.20130—
+8K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+8K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+8K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+9K252723Dynamis Pro FamilyFotona D.O.O.20260—
+9K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+9K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—