510(k) Report

Devices descending from K111136

304 later devices reach Expedium Spine System, Viper System, Viper 2 System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K2316554CIS® Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd.20240—
+1K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+1K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+1K1904714CIS® Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd.20196—
+1K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+1K172808CosmoLock Pedicle Screw SystemKalitec Direct, LLC20172—
+1K171582NEO Pedicle Screw System™Neo Medical SA20170—
+1K160904Expedium Spine System, VIPER and VIPER 2 SystemsMedos International SARL201674—
+1K142185Expedium Verse Spine SystemDepuy Spine, Inc.201420—
+1K142460EXPEDIUM Spine System/Synapse SystemJohnson and Johnson201401
+1K141509Isola and Expedium Growing Spine SystemsMedos Sarl20146—
+1K131802Expedium, Viper. Viper 2 Spine SystemDepuy Spine, A Johnson & Johnson Company2013139—
+1K130877Expedium Spine SystemMedos International SARL20138—
+1K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+1K122877Range Spinal System, Small StatureK2m, Inc.201334—
+2K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+2K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+2K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+2K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+2K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+2K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+2K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+2K231479TriALTIS Spine SystemMedos International SARL20238—
+2K230974NIDO™ Pedicle Screw SystemKalitec Medical20230—
+2K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+2K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+2K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+2K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+2K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+2K2032334CIS Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd.20221—
+2K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+2K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+2K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+2K211323ASTRA Spine SystemSpinecraft, LLC202112—
+2K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+2K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+2K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+2K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+2K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—
+2K191726mont blanc & mont blanc MIS Spinal SystemsSpineway SA20190—
+2K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+2K190376PASS LP Spinal SystemMedicrea International SA201915
+2K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+2K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+2K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+2K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+2K171421VERTICALE® Posterior Spinal Fixation System/VERTICALE® SystemSilony Medical GmbH20186—
+2K170163Erisma® LP Spinal Fixation SystemClariance, Sas20172—
+2K162912VIPER PRIME™ additions to the VIPER® SystemMedos International SARL201649—
+2K161387Mont Blanc and Mont Blanc MIS Spinal SystemsSpineway SA20163—
+2K161028K2M Growing Spine SystemK2m, Inc.20163—
+2K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+2K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+2K150417Astra Spine SystemSpinecraft, LLC201521—
+2K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+2K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+2K143200MIS Z-Pedicle Screw SystemZ-Medical GmbH & Co. KG201514—
+2K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+2K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+2K142587Vertical Expandable Prosthetic Titanium RibDepuy Synthes Spine, Inc.201411
+2K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+2K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+2K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+2K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+3K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+3K253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.20260—
+3K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+3K253249TriALTIS™ Spine SystemMedos International SARL20251—
+3K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+3K243249TriALTIS™ Spine SystemMedos International SARL20250—
+3K243693NEO Pedicle Screw System™Neo Medical SA20240—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+3K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+3K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+3K233105RESPONSE™ Rib and Pelvic SystemOrthoPediatrics Corp.20240—
+3K233684TriALTIS™ Spine SystemMedos International SARL20234—
+3K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+3K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+3K231658VEOS Spinal Fixation SystemSpineway20230—
+3K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+3K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+3K223806VERTICALE® Triangular Fixation SystemSilony Medical GmbH20230—
+3K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+3K223273ASTRA Spine SystemSpinecraft, LLC20228—
+3K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+3K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+3K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+3K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+3K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+3K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+3K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+3K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+3K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+3K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+3K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+3K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+3K192680Percusys® Plus Pedicle Screw SystemJoimax GmbH20190—
+3K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—