510(k) Report

Devices descending from K101993

162 later devices reach Viper System, Expedium System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+1K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+1K133369Tiger Spine SystemCorelink, LLC201429—
+1K131802Expedium, Viper. Viper 2 Spine SystemDepuy Spine, A Johnson & Johnson Company2013139—
+1K121130Polaris Spinal System-Ballista Spinal RodsBiomet Spine20121—
+1K110216Expedium System, Viper SystemDepuy Spine, Inc.20114—
+2K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+2K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+2K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+2K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+2K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+2K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+2K193219G Surgical Marksman SystemG Surgical, LLC20191—
+2K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—
+2K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+2K191726mont blanc & mont blanc MIS Spinal SystemsSpineway SA20190—
+2K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+2K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+2K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+2K171421VERTICALE® Posterior Spinal Fixation System/VERTICALE® SystemSilony Medical GmbH20186—
+2K171582NEO Pedicle Screw System™Neo Medical SA20170—
+2K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+2K161387Mont Blanc and Mont Blanc MIS Spinal SystemsSpineway SA20163—
+2K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+2K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+2K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+2K150417Astra Spine SystemSpinecraft, LLC201521—
+2K143200MIS Z-Pedicle Screw SystemZ-Medical GmbH & Co. KG201514—
+2K123451Polaris Spinal System - Ballista II RodsBiomet Spine (Aka Ebi, LLC)20120—
+2K120928Synthes Matrix SystemSynthes Spine20120—
+3K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+3K253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.20260—
+3K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+3K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+3K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+3K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+3K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+3K231658VEOS Spinal Fixation SystemSpineway20230—
+3K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+3K223806VERTICALE® Triangular Fixation SystemSilony Medical GmbH20230—
+3K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+3K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+3K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+3K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+3K223273ASTRA Spine SystemSpinecraft, LLC20228—
+3K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+3K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+3K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+3K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+3K211323ASTRA Spine SystemSpinecraft, LLC202112—
+3K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+3K203452Nano FortiFix® SystemNanovis, LLC20200—
+3K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+3K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+3K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+3K192680Percusys® Plus Pedicle Screw SystemJoimax GmbH20190—
+3K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+3K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+3K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+3K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+3K162786PASS LP Spinal SystemMedicrea International SA20176—
+3K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+3K151727Everest Spinal SystemK2m, Inc.201511—
+4K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+4K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+4K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K243693NEO Pedicle Screw System™Neo Medical SA20240—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+4K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+4K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+4K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+4K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+4K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+4K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+4K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+4K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+4K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+4K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+4K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+4K182240PASS LP Spinal SystemMedicrea International SA20182—
+4K161369EVEREST Spinal SystemK2m, Incorporated20169—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+5K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+5K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+5K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+5K252322SIros-X SystemGenesys Spine20250—
+5K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+5K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+5K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+5K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+5K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—