510(k) Report

Devices descending from K091445

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+5K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+5K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+5K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+5K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+5K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+5K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+5K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+5K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+5K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+5K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+5K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+5K252322SIros-X SystemGenesys Spine20250—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+5K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+5K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+5K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+5K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+5K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+5K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+5K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+5K233256Robotic Integration InstrumentsDePuy Synthes20240—
+5K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+5K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+5K240526POWEReam Xia/SerratoStryker Instruments20240—
+5K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+5K234051Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion…Spinal Simplicity, LLC20241—
+5K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+5K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+5K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+5K231658VEOS Spinal Fixation SystemSpineway20230—
+5K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+5K231479TriALTIS Spine SystemMedos International SARL20238—
+5K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+5K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+5K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+5K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC20230—
+5K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+5K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+5K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+5K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+5K222698CUVIS-spineCurexo, Inc.20220—
+5K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+5K211981KHEIRON® Spinal Fixation SystemS.M.A.I.O20228—
+5K213659LigaPASS™ 2.0 Ligament Augmentation SystemMedicrea International SA20222—
+5K220888MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A.20221—
+5K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+5K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+5K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+5K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+5K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+5K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+5K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+5K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+5K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+5K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+5K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+5K202771CD Horizon Spinal SystemMedtronic202021—
+5K201006K2M Navigation InstrumentsK2m, Inc.20200—
+5K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+5K190418NuVasive® VersaTie® SystemNu Vasive, Incorporated20190—
+5K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+5K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+5K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+5K181883FIREFLY® Midline Navigation GuideMighty Oak Medical, Inc.20184—
+5K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20185—
+5K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+5K173506LigaPASSMedicrea International SA20189—
+5K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+5K160640PASS XS Spinal SystemMedicrea International SA20160—
+5K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+5K161627PASS LP Spinal SystemMedicrea International SA20167—
+5K153413PASS LP Spinal SystemMedicrea International SA20160—
+5K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+5K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+5K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+6K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+6K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+6K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+6K253472FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical20260—
+6K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+6K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+6K253250Minuteman® G6 MIS Fusion PlateSpinal Simplicity, LLC20250—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+6K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+6K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+6K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+6K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+6K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+6K243249TriALTIS™ Spine SystemMedos International SARL20250—
+6K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—