510(k) Report

Devices descending from K131321

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+5K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+5K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+5K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+5K182240PASS LP Spinal SystemMedicrea International SA20182—
+5K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+5K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+5K173508Everest Spinal SystemK2m20189—
+5K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+5K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+5K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+6K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+6K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+6K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+6K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+6K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+6K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+6K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+6K240526POWEReam Xia/SerratoStryker Instruments20240—
+6K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+6K231479TriALTIS Spine SystemMedos International SARL20238—
+6K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+6K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+6K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+6K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+6K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+6K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+6K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+6K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+6K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+6K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+6K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+6K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+6K190376PASS LP Spinal SystemMedicrea International SA201915
+6K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+6K180376K2M Patient Specific RodsK2m, Inc.20182—
+7K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+7K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+7K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+7K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+7K243249TriALTIS™ Spine SystemMedos International SARL20250—
+7K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+7K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+7K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+7K233684TriALTIS™ Spine SystemMedos International SARL20234—
+7K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+7K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+7K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+7K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+7K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+7K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+7K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+7K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+7K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+7K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+7K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+7K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+8K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+8K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+8K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+8K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+8K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+8K242042TriALTIS™ Spine SystemMedos International SARL20241—
+8K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+8K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+8K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+8K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+8K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+8K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+8K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+8K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+8K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+8K222789VADER® Pedicle System, G21 CementIcotec AG202352
+8K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+9K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+9K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+9K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+9K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+9K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+9K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+9K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+9K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+9K232628VADER® Pedicle SystemIcotec AG20241—
+9K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+10K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—