510(k) Report

Devices descending from K943589

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K252087Navigation Module of the Cortium® SystemUlrich Medical USA, Inc.20260—
+5K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260—
+5K250815Hubly Drill (H100)Hubly, Inc.20250—
+5K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+5K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+5K252322SIros-X SystemGenesys Spine20250—
+5K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+5K250247panaSIa SI Fusion SystemWenzel Spine, Inc.20250—
+5K251395The Rialto™ SI Fusion SystemMedtronic Sofamor Danek USA, Inc.20251—
+5K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+5K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+5K242806Medyssey Navigation SystemMedyssey Co, Ltd.20250—
+5K250182Innovasis Navigation InstrumentsInnovasis, Inc.202521
+5K250380Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo…Surgify Medical OY202525
+5K243698Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment…Brainlab AG20250—
+5K243073AnyPlus Navigated Instruments SystemGS Medical Co., Ltd.20240—
+5K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+5K233036Ultrasonic Surgical SystemHunan Handlike Minimally Invasive Surgery Co., Ltd.20240—
+5K241008Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Handpiece…Relign Corporation, Subsidiary of Zimmer Biomet20240—
+5K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+5K233595Genesys Spine Sacroiliac Joint Fusion System with NavigationGenesys Spine20241—
+5K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+5K233972Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies20241—
+5K232800Navigation Tracking InstrumentsSI-BONE, Inc.20240—
+5K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+5K233493Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Shaver Handpiece…Relign Corporation20231—
+5K232211REUNION Sacroiliac Joint Fusion SystemAstura Medical20231—
+5K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+5K223864Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial…Brainlab AG20231—
+5K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+5K231829Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical20232—
+5K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+5K230087“POINT” Kinguide Agile Hybrid Navigation SystemPoint Robotics MedTech, Inc.20233—
+5K223808Zavation Navigation Instrument SystemZavation Medical Products, LLC20230—
+5K230369EUROPA™ Navigated InstrumentsMiRus, LLC20230—
+5K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+5K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+5K223511Excella Navigation InstrumentsInnovasis, Inc.20233—
+5K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+5K223494CD Horizon Spinal SystemMedtronic202317—
+5K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+5K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+5K221047SILO TFX MIS Sacroiliac Joint Fixation SystemAurora Spine, Inc.20229—
+5K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+5K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+5K221244CD Horizon™ Spinal SystemMedtronic202220—
+5K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+5K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+5K220291NEXXT SPINE NAVIGATION SystemNexxt Spine, LLC20220—
+5K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+5K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.20218—
+5K213454Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8…Medtronic Powered Surgical Solutions20210—
+5K210989Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic…Brainlab AG20212—
+5K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+5K212028Dark Star Navigation Instrument SystemRepublic Spine, LLC20210—
+5K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+5K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+5K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+5K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+5K203816DeGen Navigated InstrumentationDegen Medical20211—
+5K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—
+5K202956Erisma LP Navigated InstrumentsClariance, Sas20210—
+5K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+5K203291CD Horizon Spinal System InstrumentsMedtronic Sofamor Danek USA, Inc.202035—
+5K202552Midas Rex Attachments and Dissecting ToolsMedtronic Powered Surgical Solutions (Mpss)20200—
+5K202771CD Horizon Spinal SystemMedtronic202021—
+5K200845Navigation Module of the Momentum SystemUlrich Medical USA20200—
+5K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic202038—
+5K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+5K190580NADIA SI Fusion SystemIlion Medical, Inc.20203—
+5K200791Navigation Enabled IntrumentsMedos International SARL20205—
+5K200095Streamline Navigated InstrumentsPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.202004
+5K200841Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11Ethicon Endo-Surgery, LLC20204—
+5K193656SkyPulseFotona D.O.O.202011—
+5K192495Black Diamond Navigation InstrumentsOsseus Fusion Systems20200—
+5K190881Spinal Elements Navigated InstrumentsSpinal Elements, Inc.20194—
+5K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+5K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+5K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+5K181606Precision Spine Navigation InstrumentationPrecision Spine, Inc.20193—
+5K191748Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine201922—
+5K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.201950—
+5K183630SPINEART Navigation Instrument SystemSpineart SA20196—
+5K183381Navigation Enabled InstrumentsStryker20191—
+5K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+5K182982BridalVeil Navigated InstrumentsAstura Medical20190—
+5K182121CD HORIZON Spinal System Instruments for use with MAZOR X Stealth EditionMedtronic Sofamor Danek USA, Inc.201841—
+5K181596Spine Wave Navigated InstrumentsSpine Wave, Inc.20181—
+5K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc.201830—
+5K172517SeaSpine Navigation SystemSeaSpine Orthopedics Corporation2018601
+5K172166OLYMPIC Navigated InstrumentsAstura Medical20185—
+5K172464XD880A Ultrasonic Osteotomy Surgical SystemMorley Research Consortium20182—
+5K173740Reprocessed DePuy Mitek Ablation WandRenovo, Inc.20180—
+5K172115Navigated Instrument SystemOrthofix, Inc.20184—
+5K173285Joule SystemSciton, Inc20185—
+5K172518Spineology Navigation InstrumentsSpineology, Inc.20184—
+5K172623NuVasive Navigation InstrumentsNu Vasive, Incorporated20176—
+5K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—