510(k) Report

Devices descending from K041939

718 later devices reach Blackstone Peek Vertebral Body Replacement System Lordotic Lateral Spacers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+8K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+8K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+8K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+8K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+8K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+8K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+8K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+8K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+8K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+8K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+8K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+8K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+8K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+8K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+8K211306LabyrinthZavation Medical Products, LLC20213—
+8K210728CONDUIT InstrumentsMedos International SARL20215—
+8K203444BEE HA CageNGMedical GmbH20211—
+8K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+8K201287Impulse Interbody Fusion SystemDegen Medical20208—
+8K200084Zavation IBF SystemZavation Medical Products, LLC20208—
+8K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+8K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+8K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+8K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+8K190680Favo S-TlifSilony Medical GmbH20190—
+8K182608Oyster ACIF CageSilony Medical GmbH20190—
+8K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+8K181792Duo™ Lumbar Interbody Fusion DeviceSpineology, Inc.20183—
+8K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc.20182—
+8K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+9K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+9K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+9K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+9K261408SABER-XA SystemElevation Spine20260—
+9K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+9K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+9K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+9K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+9K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+9K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+9K250769Dakota LP SystemPrecision Spine, Inc.20250—
+9K250560BEE HANGMedical GmbH20250—
+9K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+9K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+9K252742Navigated InstrumentsTyber Medical, LLC20251—
+9K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+9K252322SIros-X SystemGenesys Spine20250—
+9K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+9K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+9K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+9K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+9K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+9K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K243474MagnetOs MISKuros Biosciences B.V20250—
+9K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+9K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+9K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+9K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+9K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+9K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+9K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+9K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+9K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+9K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+9K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+9K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+9K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+9K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+9K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+9K240453ReBOSSISOrthorebirth Co., Ltd.202402
+9K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+9K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+9K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+9K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+9K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+9K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+9K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+9K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+9K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+9K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+9K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+9K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+9K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+9K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+10K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+10K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+10K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+10K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+10K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+10K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+10K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+10K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+10K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+10K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+10K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+10K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+10K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—