510(k) Report

Devices descending from K002824

254 later devices reach Macs Modular Anterior Construct System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123939S4 Spinal SystemAesculap Implant Systems, Inc.20133—
+1K101353Golden Gate Anterior Plate SystemUlrich GmbH & Co. KG20110—
+1K032059Modification to Macs Modular Anterior Construct SystemAesculap, Inc.2003250—
+2K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+2K070387Expedium Spine SystemDepuy Spine, Inc.2007248—
+3K180433Ennovate®Aesculap Implant Systems, LLC201811
+3K142185Expedium Verse Spine SystemDepuy Spine, Inc.201420—
+3K111571Viper SystemsJohnson & Johnson2011203—
+3K102249Expedium Spine SystemDepuy Spine, A Johnson & Johnson Company2010218—
+3K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+4K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+4K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+4K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+4K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+4K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+4K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+4K182240PASS LP Spinal SystemMedicrea International SA20182—
+4K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+4K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+4K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+4K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+4K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+4K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+4K121728Tiger Spine SystemCorelink, LLC201250—
+4K121172Reform Pedicle Screw SystemSpinal USA201233—
+4K121016Range Spinal System (Mesa and Denali)K2m, Inc.201238—
+4K121020Viper SystemDepuy Spine, Inc.201294—
+4K120696Tiger Spine SystemCorelink, LLC201241—
+4K080767Conquest Spinal SystemLife Spine200821—
+5K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+5K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+5K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K253249TriALTIS™ Spine SystemMedos International SARL20251—
+5K252437JAZZ Spinal SystemImplanet20250—
+5K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+5K240392JAZZ Spinal SystemImplanet20241—
+5K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+5K231658VEOS Spinal Fixation SystemSpineway20230—
+5K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+5K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+5K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+5K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+5K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+5K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+5K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+5K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+5K190376PASS LP Spinal SystemMedicrea International SA201915
+5K181339Altus Spine Pedicle Screw SystemAltus Partners, LLC20186—
+5K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc.20171—
+5K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+5K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+5K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+5K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+5K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+5K141147Range Spinal SystemK2m, Inc.20141—
+5K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+5K133369Tiger Spine SystemCorelink, LLC201429—
+5K131250Tiger Spine SystemCorelink, LLC201340—
+5K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+5K131343Reform Pedicle Screw SystemSpinal USA201331—
+5K130279Reform Pedicle Screw SystemSpinal USA201331—
+5K131030Range Spinal SystemK2m, Inc.201334—
+5K130330Range Spinal SystemK2m, Inc.201336—
+5K123487Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC20130—
+5K123373Nautilus Spinal SystemLife Spine201317—
+5K111953Nautilus Spinal SystemLife Spine20123—
+5K090320Conquest Spinal SystemLife Spine20092—
+6K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+6K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+6K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+6K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+6K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+6K252322SIros-X SystemGenesys Spine20250—
+6K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+6K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+6K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+6K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+6K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+6K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+6K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+6K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+6K231479TriALTIS Spine SystemMedos International SARL20238—
+6K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+6K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+6K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+6K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+6K221244CD Horizon™ Spinal SystemMedtronic202220—
+6K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+6K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+6K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+6K220025ARx® Spinal SystemLife Spine, Inc.20220—
+6K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+6K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+6K210549ARx Spinal SystemLife Spine, Inc.20211—
+6K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+6K203452Nano FortiFix® SystemNanovis, LLC20200—
+6K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+6K200322Altus Spine Pedicle Screw SystemAltus Partners, LLC20204—
+6K200303Reform Pedicle Screw SystemPrecision Spine202010—