510(k) Report

Devices descending from K092901

609 later devices reach Epicage Interbody Fusion Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+7K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+7K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+7K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+7K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+7K201585Monterey AL Interbody SystemStryker Corporation202044
+7K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+7K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+7K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+7K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+7K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+7K200312Tryptik TiSpineart20202—
+7K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+7K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+7K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+7K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+7K191134IB3D AlifMedicrea International SA20191—
+7K1803473d CageFims Co., Ltd.20190—
+7K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+7K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+7K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+7K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+7K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+7K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+7K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+7K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+7K183092Kuros TLIF CageKuros Biosciences B.V20190—
+7K182584Lucent® XPSpinal Elements, Inc.20183—
+7K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+7K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+7K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+7K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+7K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+7K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+8K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+8K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+8K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+8K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+8K262094E3D™-C Interbody SystemEvolution Spine20260—
+8K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+8K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+8K260810Anteralign LS coverplateTyber Medical, LLC20260—
+8K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+8K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+8K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+8K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+8K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+8K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+8K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+8K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+8K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+8K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+8K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+8K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+8K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+8K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+8K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+8K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+8K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+8K243188Cylox® STSignus Medizintechnik GmbH20250—
+8K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+8K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+8K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+8K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+8K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+8K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+8K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+8K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+8K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+8K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+8K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+8K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+8K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+8K240699SCARLET® AC-TiSpineart SA20240—
+8K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+8K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+8K234150Lucent® XPSpinal Elements20240—
+8K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+8K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+8K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+8K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+8K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+8K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+8K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+8K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+8K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+8K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+8K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+8K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+8K230583Tryptik TiSpineart SA20231—
+8K223418DeGen Impulse AM™ SystemDegen Medical20236—
+8K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+8K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+8K223494CD Horizon Spinal SystemMedtronic202317—
+8K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+8K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+8K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+8K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+8K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+8K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—