510(k) Report

Devices descending from K082235

693 later devices reach Blackstone Pillar XL Peek Spacers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+9K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+9K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+9K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+9K230329F3D Interbody SystemCorelink, LLC20230—
+9K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+9K221578Hexanium ACIFSpinevision, S.A.S.20224—
+9K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+9K213417Ghost Spacer SystemLife Spine, Inc.20220—
+9K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+9K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+9K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+9K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+9K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+9K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+9K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+9K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+9K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+9K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+9K212562Idys-C ZP 3DTiClariance, SA20211—
+9K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+9K211413BEE PLIF CageNGMedical GmbH20211—
+9K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+9K211306LabyrinthZavation Medical Products, LLC20213—
+9K210728CONDUIT InstrumentsMedos International SARL20215—
+9K202032Idys LLIF 3DTiClariance, Sas20210—
+9K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+9K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+9K201287Impulse Interbody Fusion SystemDegen Medical20208—
+9K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+9K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+9K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+9K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+9K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+9K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+9K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+9K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+9K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+10K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+10K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+10K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+10K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+10K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+10K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+10K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+10K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+10K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+10K252742Navigated InstrumentsTyber Medical, LLC20251—
+10K252322SIros-X SystemGenesys Spine20250—
+10K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+10K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+10K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+10K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+10K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+10K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+10K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+10K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+10K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+10K240715Idys® C ZP 3DTiClariance20240—
+10K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+10K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+10K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+10K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+10K223418DeGen Impulse AM™ SystemDegen Medical20236—
+10K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+10K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+10K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+10K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+10K212358Romero Cervical CageSpineup, Inc.20226—
+10K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+10K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+10K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+11K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+11K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+11K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+11K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+11K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+11K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+11K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+11K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+11K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+11K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+11K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+11K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+11K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+11K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+11K230026SqualeImplanet, S.A.20230—
+11K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+12K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+12K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+12K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+12K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+12K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—