510(k) Report

Devices descending from K943589

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K171267NavLock TrackersMedtronic Navigation201741
+5K163610PIEZOTOME M+, PIEZOTOME M+ HandpieceSatalec-Acteon Group20170—
+5K162921Navigated Instrument SystemOrthofix, Inc.20175—
+5K163548ENSEAL X1 Large Jaw Tissue SealerEthicon Endo-Surgery, LLC20170—
+5K153587Taps for Resorbable ScrewsSynthes (USA) Products, LLC20170—
+5K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+5K153743Piezosurgery PlusMectron S.P.A.20162—
+5K153603Alphatec Navigation InstrumentsAlphatec Spine, Inc.201679—
+5K153203Navigation InstrumentsGlobus Medical, Inc.2016112—
+5K152777Bovie Disposable Bipolar AblatorBovie Medical Corporation201632
+5K150231Navigated Disc Prep Instruments and CAPSTONE TrialsMedtronic Sofamor Danek USA, Inc.2015242—
+5K143475VAPR Tripolar Suction ElectrodeDepuy Mitek201501
+5K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015207—
+5K143628Navigated Vertex Select InstrumentsMedtronic Sofamor Danek USA, Inc.2015206—
+5K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+5K140896Vapr Arctic Suction ElectrodeDepuy Mitek, A Johnson & Johnson Company20140—
+5K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+5K132976AdvatxAdvalight Aps20141—
+5K131425Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale InserterMedtronic Navigation, Inc.201324610
+5K120095Side Effect with Hand Controls, Hook Electrode with Hand Controls, 2.3 Wedge Electrode…Depuy Mitek, A Johnson & Johnson Company20120—
+5K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+5K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+5K101573Accusculpt II Laser SystemLutronic Corporation20101—
+5K093048D-Storm 810NM, D-Storm 980NMLight Instruments20100—
+5K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+5K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+5K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+5K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+5K081352Profile Multi-Platform SystemSciton, Inc2008112—
+5K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+5K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc.20081—
+5K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+5K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+6K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC20260—
+6K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+6K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+6K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+6K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+6K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+6K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+6K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+6K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical20260—
+6K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+6K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+6K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+6K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+6K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K253331PressON Spinal Fixation SystemNexus Spine20250—
+6K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+6K252437JAZZ Spinal SystemImplanet20250—
+6K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+6K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+6K243280Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro…W&H Dentalwerk Buermoos GmbH20250—
+6K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521
+6K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+6K242464Stealth™ Spine Clamps; ModuLeX™ Shank MountsMedtronic Navigation, Inc.20251—
+6K251433Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo…Surgify Medical OY202513
+6K250189AdvaTxAdvalight Aps20250—
+6K250403Catamaran SI Joint Fusion SystemTenon Medical20251—
+6K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+6K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+6K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+6K243067The ETHICON™ Total Energy SystemEthicon Endo-Surgery, LLC (A Johnson and Johnson Company)20250—
+6K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+6K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+6K241895Cannulated PsiFGuardSpineguard20240—
+6K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+6K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20241—
+6K241644SPINEART Navigation Instrument SystemSpineart SA20243—
+6K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+6K241130“POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000)Point Robotics MedTech, Inc.20242—
+6K241606Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed…Stryker Sustainability Solutions20240—
+6K233256Robotic Integration InstrumentsDePuy Synthes20240—
+6K233255CROSSNAV Navigation Enabled InstrumentsDePuy Synthes20242—
+6K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+6K240963Spinal SystemTeslake, Inc.20240—
+6K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+6K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+6K240392JAZZ Spinal SystemImplanet20241—
+6K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+6K232149BowTie™ SI Joint Fusion SystemSail Fusion, LLC20242—
+6K232259Patriot-SI Posterior Implant SystemSpinal Simplicity, LLC20241—
+6K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+6K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+6K233471Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed…Stryker Sustainability Solutions20241—
+6K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+6K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+6K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+6K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+6K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+6K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+6K231527TriALTIS Navigation Enabled InstrumentsMedos International Sàrl20233—
+6K230857TiLink-P SI Joint Fusion SystemSurGenTec, LLC20234—
+6K231944CATAMARAN SI Joint Fusion SystemTenon Medical, Inc.20234—
+6K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+6K231126Eblator DeviceE Surgical, LLC20231—
+6K230716Robotic Graft Delivery InstrumentsMedtronic Sofamor Danek, Inc.20230—