510(k) Report

Devices descending from K132471

132 later devices reach CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221244CD Horizon™ Spinal SystemMedtronic202220—
+1K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+1K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.20162—
+1K150178CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201525—
+1K140010Fortress Pedicle Screw SystemSpineology, Inc.201411—
+1K140276CD Horizon Spinal SystemMedtronic Sofamor Danek201485—
+1K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+2K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+2K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+2K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+2K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+2K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+2K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+2K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+2K223494CD Horizon Spinal SystemMedtronic202317—
+2K191575ARx Spinal SystemLife Spine, Inc.201910—
+2K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+2K173126Arisstos™ Spinal SystemIngenium Spine20171—
+2K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+2K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+2K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+2K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+2K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—
+2K143403Threshold Pedicular Fixation SystemSpineology, Inc.20148—
+2K142381Xia 3 Spinal SystemStryker Corp.201483—
+2K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+3K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+3K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+3K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+3K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+3K253331PressON Spinal Fixation SystemNexus Spine20250—
+3K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+3K241258Ingenix Spinal SystemIngenium Spine20240—
+3K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+3K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+3K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+3K220025ARx® Spinal SystemLife Spine, Inc.20220—
+3K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+3K210549ARx Spinal SystemLife Spine, Inc.20211—
+3K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+3K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+3K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+3K200666Stryker Xia 3 Power AdaptorStryker Spine20203—
+3K200070ARx Spinal SystemLife Spine, Inc.20209—
+3K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+3K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+3K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+3K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+3K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+3K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation20179—
+3K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+3K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+3K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+3K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151
+3K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+3K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+3K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+3K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+3K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+3K151216Everest Spinal SystemK2m, Inc.201511—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+4K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+4K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+4K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+4K252322SIros-X SystemGenesys Spine20250—
+4K253249TriALTIS™ Spine SystemMedos International SARL20251—
+4K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+4K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+4K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+4K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+4K233300POWEReam 1/4 DriveStryker Instruments20231—
+4K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+4K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+4K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+4K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+4K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+4K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+4K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+4K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+4K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+4K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+4K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+4K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+4K182240PASS LP Spinal SystemMedicrea International SA20182—
+4K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+4K173508Everest Spinal SystemK2m20189—
+4K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+5K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+5K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+5K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+5K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+5K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—