510(k) Report

Devices descending from K082235

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K200919Idys ALIF 3DTiClariance20210—
+8K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+8K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+8K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+8K202637F3D Corpectomy SystemCorelink, LLC20201—
+8K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+8K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+8K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+8K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+8K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+8K200316UNiD IB3D ALIFMedicrea International SA20200—
+8K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+8K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+8K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+8K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+8K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+8K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+8K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+8K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+8K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+8K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+8K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+8K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+8K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+8K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+8K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+8K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+8K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+8K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+8K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+8K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+8K183064TxTi IBF SystemInnovasis, Inc.2019481
+8K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+8K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+8K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+8K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+8K182349Concorde LiftMedos International SARL20190—
+8K183092Kuros TLIF CageKuros Biosciences B.V20190—
+8K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+8K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+8K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+8K181702Tranquil-L Interbody SystemNexus Spine, LLC20188—
+8K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+8K173537Concorde Lift™Medos International SARL20181—
+9K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+9K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+9K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+9K261279DeltaNEC Interbody SystemNexus Spine20260—
+9K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+9K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+9K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+9K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+9K261067BEE PLIF CageNGMedical GmbH20260—
+9K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+9K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+9K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+9K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+9K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+9K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+9K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+9K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+9K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+9K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+9K253331PressON Spinal Fixation SystemNexus Spine20250—
+9K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+9K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+9K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+9K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+9K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+9K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+9K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+9K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+9K243474MagnetOs MISKuros Biosciences B.V20250—
+9K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+9K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+9K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+9K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+9K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+9K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+9K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+9K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+9K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+9K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+9K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+9K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+9K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+9K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+9K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+9K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+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—
+9K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+9K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+9K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+9K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+9K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+9K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+9K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—