510(k) Report

Devices descending from K031276

128 later devices reach Synthes Anterior Cervical Locking Plate (Aclp) System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210424Quantum Anterior Cervical PlateNvision Biomedical Technologies, Inc.20214—
+1K210325APOLLO Anterior Cervical Plate (ACP) SystemAurora Spine, Inc.20210—
+1K191786Cyclops™ Anterior Cervical Plate SystemDegen Medical, Inc.20191—
+1K173867Axis Anterior Cervical Plate SystemAxis Orthopaedics20181—
+1K172585Liberty Anterior Cervical PlateValorus Spine20170—
+1K161524Tangis Anterior Cervical PlateNvision Biomedical Technologies, LLC20168—
+1K151553Anterior Cervical Plate SystemOsteomed Implantes, Ltda201611—
+1K141500Optio-C Anterior Cervical SystemZimmer Spine, Inc.20142—
+1K131512Katia SystemShanghai Sanyou Medical Co, Ltd.20131—
+1K121078Van Gogh Anterior Cervical Plate SystemAccel Spine20120—
+1K113509Lexus Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.201219—
+1K103137Venus Anterior Cervical PlateVerticor, Ltd.20115—
+1K042073Olsen Medical Anterior Cervical Vertebrae Plate SystemOlsen Medical20050—
+1K033844Synthes Anterior Cervical Compression SystemSynthes (Usa)200491—
+2K252611aprevo® cervical plating systemCarlsmed, Inc.20253—
+2K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+2K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+2K213901Cyclops™ Anterior Cervical Plate SystemDegen Medical20220—
+2K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+2K203154KASILOF Cervical Plate SystemKahtnu Surgical, Inc.20200—
+2K173091Boundary Anterior Lumbar Buttress PlateNvision Biomedical Technologies, LLC20170—
+2K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+2K152239Zero-P Natural Plate SystemSynthes (Usa), LLC20150—
+2K143271CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.201515—
+2K143279LnK Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20155—
+2K111132Genesys Spine Anterior Cervical Plate SystemGenesys Spine201141
+2K050451Synthes Vectra SystemSynthes Spine Co.Lp2005843
+3K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+3K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+3K260570corra™ cervical plating systemCarlsmed, Inc.20261—
+3K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+3K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+3K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc.20233—
+3K190425CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.201913—
+3K183409Athena II Cervical Plate SystemMedyssey USA, Inc.20191—
+3K183073SMG Anterior Cervical Plate SystemSapphire Medical Group20190—
+3K181190Pinehurst Anterior Cervical Plate SystemSignature Orthopaedics Pty, Ltd.20190—
+3K180022Athena Cervical Plate SystemMedyssey USA, Inc.20182—
+3K171797TRYPTIK2 C-Plate Anterior Cervical Plate SystemSpineart20180—
+3K133245Genesys Spine Anterior Cervical Plate II SystemGenesys Spine201411
+3K140361Meta-C Cervical PlateMedacta International20140—
+3K112068Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp2011331
+3K071667Synthes Vectra-One SystemSynthes Spine2007263
+3K061147Opteryx Anterior Cervical Plate SystemInnovasis, Inc.200611
+3K051665Synthes Vectra-T SystemSynthes Spine2005492
+4K262149corra® cervical plating systemCarlsmed, Inc.20260—
+4K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+4K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+4K240592Wolff's Law Anterior Cervical Plate SystemSpinal Simplicity, LLC20240—
+4K230301Athena III Cervical Plate SystemMedyssey USA, Inc.20230—
+4K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine202110—
+4K202878Prase-AP Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20211—
+4K192049Oryx Cervical Plate SystemInnovasis, Inc.201901
+4K192076Binary® Anterior Cervical Plate SystemGenesys Spine20190—
+4K143576Exactech AmbassadorExactech, Inc.201571
+4K130030Zavation Cervical Plate SystemZavation, LLC201315—
+4K121852Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp201230—
+4K112748Slimplicity Solo Anterior Cervical Plate SystemSpinal USA, LLC20120—
+4K121049Unify Dynamic Anterior Cervical Plate SystemGlobus Medical, Inc.201210—
+4K111135Pyrenees Cervical Plate System (Translational Plates)K2m, Inc.20111—
+4K073500Active Anterior Cervical Plate SystemSanacor20080—
+5K231840CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20230—
+5K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20231—
+5K221053Magnes-C Anterior Cervical Plate SystemFellowship of Orthopaedic Researchers, Inc.20230—
+5K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc.20232—
+5K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc.20226—
+5K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+5K200170SpineNet SSP SystemSpinenet, LLC20200—
+5K192314RESONATE Anterior Cervical Plate SystemGlobus Medical, Inc.20193—
+5K190227Boomerang™ Anterior Cervical Plate SystemChoicespine, LP20194—
+5K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+5K181549Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate…Curiteva, LLC20180—
+5K172104Ozark (tm) Cervical Plate SystemK2m, Inc.20175—
+5K152455Amendia Cervical Plate SystemAmendia, Inc.20151—
+5K150666uNion Cervical Plate SystemUlrich Medical USA201531
+5K142212Pyrenees Cervical Plate SystemK2m, Inc.20150—
+5K141005Z-Link CervicalZavation, LLC20144—
+5K133567Unify (R) Dynamic Anterior Cervical Plate SystemGlobus Medical, Inc.20145—
+5K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+6K243369Cervical Plating SystemLife Spine, Inc.20240—
+6K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+6K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+6K231251FlexWing Anterior Cervical Plate SystemJeil Medical Corporation20242—
+6K240515uNion® MAX Cervical Plate SystemUlrich Medical USA, Inc.20240—
+6K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+6K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+6K232318VICTORY™ Lumbar Plate SystemGlobus Medical, Inc.20230—
+6K231593Sapphire X3 Anterior Cervical Plate SystemSpinal Elements, Inc.20230—
+6K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+6K202227Artus™ cervical plate systemUlrich GmbH & Co. KG20200—
+6K200927Transept Cervical Plate SystemNeurostructures, Inc.20200—
+6K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+6K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate…K2m, Inc.20184—
+6K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+6K152972Amendia Stand-Alone Cervical SystemAmendia, Inc.201632
+6K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+7K253545Vulcan Spinal SystemK2m, Inc.20260—
+7K252826ARIX Femur Nail SystemJeil Medical Corporation20250—
+7K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+7K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—