510(k) Report

Devices descending from K062759

1,406 later devices reach Paramount VBR System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+8K211306LabyrinthZavation Medical Products, LLC20213—
+8K210728CONDUIT InstrumentsMedos International SARL20215—
+8K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+8K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+8K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+8K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+8K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+8K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+8K200115Cavetto-SA Cervical Cage SystemNeurostructures, Inc.202019—
+8K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+8K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+8K192897icotec Cervical CageIcotec AG20201—
+8K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+8K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+8K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+8K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+8K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+8K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+8K190885Elevation Spine Saber-C SystemElevation Spine201925—
+8K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+8K190055Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20191—
+8K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+8K182322Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+8K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+8K181014Tritanium PL CageStryker Spine2018137—
+8K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+8K181188EVEREST Spinal SystemK2m, Inc.20186—
+8K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+8K172424Velofix™ SA Cervical CageU&I Corporation201751
+8K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+8K171321K2M Navigation InstrumentsK2m201711
+8K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+8K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+8K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+8K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+8K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.20161—
+8K152622Alta ACDF SystemBiomet Spine20160—
+8K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+8K143126Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies2015237—
+9K260660SABER-C SystemElevation Spine20261—
+9K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+9K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+9K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+9K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+9K250540SABER-C SystemElevation Spine20252—
+9K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+9K242414TiLink-P Joint Fusion SystemSurGenTec, LLC20240—
+9K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+9K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+9K242141TiLink-P SI Joint Fusion SystemSurGenTec, LLC20241—
+9K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+9K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+9K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+9K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+9K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+9K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+9K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+9K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+9K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+9K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+9K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+9K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+9K210573Velofix SA Cervical CageU&I Corporation20211—
+9K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+9K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+9K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+9K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+9K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+9K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+9K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+9K201006K2M Navigation InstrumentsK2m, Inc.20200—
+9K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+9K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+9K191575ARx Spinal SystemLife Spine, Inc.201910—
+9K171425Concorde LiftMedos International SARL201782
+9K151374NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable…Nu Vasive, Incorporated2015235—
+10K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd.20260—
+10K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+10K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+10K243835TiLink-P SI Joint Fusion SystemSurGenTec, LLC20240—
+10K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+10K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+10K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+10K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+10K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+10K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+10K220025ARx® Spinal SystemLife Spine, Inc.20220—
+10K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+10K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+10K200070ARx Spinal SystemLife Spine, Inc.20209—
+10K182349Concorde LiftMedos International SARL20190—
+10K173537Concorde Lift™Medos International SARL20181—
+10K153105MLX™ - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2016234—
+11K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+11K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+11K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+11K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+11K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—