510(k) Report

Devices descending from K090353

796 later devices reach Perimeter Interbody Fusion Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+1K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+1K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+1K160418PERIMETER Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.20165—
+1K133645Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System, Perimeter…Medtronic Sofamor Danek USA, Inc.20146—
+1K132897Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.2013279—
+1K132700Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek, Inc.2013170—
+1K131296Varilift-L Interbody Fusion DeviceWenzel Spine, Inc.20130—
+1K120368Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc.2012761—
+1K113642Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA2012292—
+1K113528Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011361—
+1K111525Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2011355—
+2K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+2K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+2K242267Gemini Medical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+2K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+2K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+2K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+2K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+2K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+2K211689KEYSTONE PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20212—
+2K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+2K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+2K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+2K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+2K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+2K163422Shanghai Sanyou PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20173—
+2K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+2K171031CRESCENT™ Spinal SystemMedtronic Sofamor Danek2017144—
+2K171468FUSE Spinal SystemMedtronic Sofamor Danek20170—
+2K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+2K153665Prow Fusion-LNlt Spine, Ltd.20160—
+2K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+2K153621Juliet® TiSpineart2016751
+2K153436LATERAL Spine Truss System4Web, Inc.20165—
+2K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+2K153438PERIMETER C (Titanium) Spinal SystemMedtronic Sofamor Danek USA, Inc.20160—
+2K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+2K150321EVOS Lumbar Interbody SystemCutting Edge Spine, LLC201592—
+2K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+2K142277Juliet POSpineart2014119—
+2K140474Juliet OLSpineart2014120—
+2K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—
+2K123758Tasmin RSignus Medizintechnik GmbH20141—
+2K133650Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2013344—
+2K131669Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.2013234—
+2K123027Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc.2013709—
+2K123978Capstone L Spinal SystemMedtronic Sofamor Danek USA201313—
+2K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+2K122989Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC)2012171—
+2K121567Oracle Lumbar Intervertebral Body Fusion Cage SystemAccel Spine20125—
+2K122591Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.201214—
+2K121760Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2012723—
+2K121982Sovereign Spinal SystemMedtronic Sofamor Danek2012155—
+2K121096Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201236—
+2K120063Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201237—
+3K261049Scala® TLSpineart SA20260—
+3K261408SABER-XA SystemElevation Spine20260—
+3K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+3K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+3K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+3K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+3K241438Signus Tetris™ St; Signus Tetris™ R StSignus Medizintechnik GmbH20240—
+3K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+3K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+3K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+3K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+3K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+3K213441PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20222—
+3K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+3K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+3K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+3K212389Advantage Lumbar System - ALIF, PLIF, DLIF, TLIFIntelivation, LLC20210—
+3K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+3K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+3K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+3K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+3K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+3K200312Tryptik TiSpineart20202—
+3K200552EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20200—
+3K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+3K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+3K191796Neo Cage SystemNeo Medical SA20190—
+3K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+3K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+3K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+3K181048Neo Cage System TMNeo Medical SA20191—
+3K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+3K181899Roccia® PlifSilony Medical GmbH20180—
+3K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+3K182470Plateau Spacer SystemLife Spine20180—
+3K181818Scarlet AL-TSpineart201864—
+3K181203Juliet TiSpineart20181—
+3K180674EVOL® ha-C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20183—
+3K173189Lumfuse TPPrecifit Medical, Ltd.20180—
+3K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+3K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+3K172947HALF DOME Posterior Lumbar Interbody SystemAstura Medical201822—
+3K172816TiGer Shark™ SystemChoicespine, LP201859—
+3K173702Juliet Ti LLSpineart20182—