510(k) Report

Devices descending from K081849

753 later devices reach Blackstone Pillar SA Partial Vertebral Body Replacement Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+8K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+8K234150Lucent® XPSpinal Elements20240—
+8K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+8K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+8K223418DeGen Impulse AM™ SystemDegen Medical20236—
+8K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+8K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+8K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+8K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+8K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+8K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+8K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+8K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+8K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+8K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+8K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+8K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+8K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+8K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+8K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+8K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+8K183243Velofix TLIF CageU&I Corporation20190—
+8K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+8K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+8K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+8K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+8K181829Velofix TLIF CageU&I Corporation20181—
+9K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+9K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+9K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+9K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+9K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+9K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+9K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+9K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+9K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+9K202637F3D Corpectomy SystemCorelink, LLC20201—
+9K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+9K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+9K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+9K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+9K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+10K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+10K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+10K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+10K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+10K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+10K221578Hexanium ACIFSpinevision, S.A.S.20224—
+10K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—