510(k) Report

Devices descending from K082014

837 later devices reach Stryker Spine Avs PL Peek Spacers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+7K250769Dakota LP SystemPrecision Spine, Inc.20250—
+7K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+7K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+7K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+7K243474MagnetOs MISKuros Biosciences B.V20250—
+7K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+7K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+7K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K243188Cylox® STSignus Medizintechnik GmbH20250—
+7K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+7K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+7K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+7K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+7K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+7K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+7K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+7K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+7K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+7K234150Lucent® XPSpinal Elements20240—
+7K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+7K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+7K240453ReBOSSISOrthorebirth Co., Ltd.202402
+7K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+7K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+7K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+7K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+7K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+7K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+7K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+7K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+7K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+7K223494CD Horizon Spinal SystemMedtronic202317—
+7K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+7K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+7K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+7K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+7K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+7K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+7K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+7K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+7K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+7K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+7K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+7K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+7K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+7K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+7K211413BEE PLIF CageNGMedical GmbH20211—
+7K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+7K203003Pantheon IBFDPantheon Spinal20210—
+7K210728CONDUIT InstrumentsMedos International SARL20215—
+7K200919Idys ALIF 3DTiClariance20210—
+7K202637F3D Corpectomy SystemCorelink, LLC20201—
+7K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+7K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+7K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+7K200316UNiD IB3D ALIFMedicrea International SA20200—
+7K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+7K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+7K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+7K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+7K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+7K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+7K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+7K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+7K190680Favo S-TlifSilony Medical GmbH20190—
+7K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+7K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+7K182349Concorde LiftMedos International SARL20190—
+7K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+7K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+7K181702Tranquil-L Interbody SystemNexus Spine, LLC20188—
+7K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+7K173537Concorde Lift™Medos International SARL20181—
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+8K261279DeltaNEC Interbody SystemNexus Spine20260—
+8K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+8K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+8K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+8K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+8K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+8K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+8K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+8K252742Navigated InstrumentsTyber Medical, LLC20251—
+8K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+8K253331PressON Spinal Fixation SystemNexus Spine20250—
+8K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+8K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+8K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+8K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+8K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+8K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+8K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+8K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+8K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+8K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+8K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—