510(k) Report

Devices descending from K943589

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+9K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+9K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+9K260810Anteralign LS coverplateTyber Medical, LLC20260—
+9K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+9K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+9K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+9K253342PICO-KSpeclipse, Inc.20251—
+9K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+9K251730LIA Console (542-7)Leadoptik, Inc.20250—
+9K253344Bellus-QSpeclipse, Inc.20250—
+9K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+9K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+9K251632Optimas MAX SystemInMode, Ltd.20251—
+9K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+9K251094Alma VeilWontech Co., Ltd.20250—
+9K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+9K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+9K243835TiLink-P SI Joint Fusion SystemSurGenTec, LLC20240—
+9K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+9K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+9K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+9K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+9K241846E3D™-C Interbody SystemEvolution Spine20246—
+9K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+9K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+9K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+9K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+9K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+9K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+9K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+9K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+9K22079410PLTentech Co., Ltd.20220—
+9K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+9K222698CUVIS-spineCurexo, Inc.20220—
+9K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+9K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+9K222110Mariner RDX SystemSeaSpine Orthopedics Corporation202282
+9K221427V-LaserWontech Co., Ltd.20222—
+9K212790XLase PlusBiotec Italia, Srl20220—
+9K220195iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc.202232—
+9K220025ARx® Spinal SystemLife Spine, Inc.20220—
+9K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+9K202041Opera EvoQuanta System Spa20200—
+9K200736Stardust MedI.T.S. Group S.R.L.20200—
+9K200616E>EyeCE-Swin20200—
+9K200070ARx Spinal SystemLife Spine, Inc.20209—
+9K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+9K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+9K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+9K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+9K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+9K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+10K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+10K262094E3D™-C Interbody SystemEvolution Spine20260—
+10K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+10K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+10K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+10K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+10K260038E3D™-C Interbody SystemEvolution Spine20261—
+10K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+10K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+10K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+10K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+10K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+10K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd.20241—
+10K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+10K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+10K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+10K240368E3D™-A Interbody SystemEvolution Spine20247—
+10K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+10K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+10K232106Air Gap FiberWontech Co., Ltd.20240—
+10K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+10K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+10K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+10K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+10K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+10K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+10K222774iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.202220—
+10K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+10K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+10K210549ARx Spinal SystemLife Spine, Inc.20211—
+10K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+10K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—