510(k) Report

Devices descending from K111457

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K151727Everest Spinal SystemK2m, Inc.201511—
+3K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—
+3K151216Everest Spinal SystemK2m, Inc.201511—
+3K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+3K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+3K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+3K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+3K143403Threshold Pedicular Fixation SystemSpineology, Inc.20148—
+3K141850Flospine Pedicle Screw SystemFlospine20140—
+3K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+3K133402K2M Modular HooksK2m, Inc.20140—
+3K140529Everest Spinal SystemK2m, LLC201431—
+3K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+3K132361Everest Spinal SystemK2m, Inc.201334—
+3K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+4K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+4K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+4K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+4K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+4K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+4K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+4K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+4K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+4K253249TriALTIS™ Spine SystemMedos International SARL20251—
+4K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+4K253331PressON Spinal Fixation SystemNexus Spine20250—
+4K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+4K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+4K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+4K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+4K241258Ingenix Spinal SystemIngenium Spine20240—
+4K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+4K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+4K233300POWEReam 1/4 DriveStryker Instruments20231—
+4K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+4K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+4K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+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—
+4K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+4K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+4K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+4K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K220025ARx® Spinal SystemLife Spine, Inc.20220—
+4K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+4K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+4K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+4K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+4K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+4K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+4K200070ARx Spinal SystemLife Spine, Inc.20209—
+4K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+4K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+4K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+4K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+4K182240PASS LP Spinal SystemMedicrea International SA20182—
+4K181188EVEREST Spinal SystemK2m, Inc.20186—
+4K172115Navigated Instrument SystemOrthofix, Inc.20184—
+4K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+4K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+4K171321K2M Navigation InstrumentsK2m201711
+4K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+4K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+4K170647Connector SystemOrthofix, Inc.201718—
+4K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+4K161842Overwatch Spine SystemAmendia, Inc.201661
+4K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+4K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+4K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+4K142360Everest Spinal SystemK2m, Inc.201522—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+5K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+5K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+5K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+5K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+5K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+5K252322SIros-X SystemGenesys Spine20250—
+5K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+5K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+5K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+5K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+5K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+5K233256Robotic Integration InstrumentsDePuy Synthes20240—
+5K240526POWEReam Xia/SerratoStryker Instruments20240—
+5K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+5K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+5K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+5K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+5K231479TriALTIS Spine SystemMedos International SARL20238—
+5K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+5K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+5K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—