510(k) Report

Devices descending from K090816

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+6K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+6K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+6K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+6K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+6K211413BEE PLIF CageNGMedical GmbH20211—
+6K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+6K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+6K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+6K210728CONDUIT InstrumentsMedos International SARL20215—
+6K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+6K210359Hexanium TLIFSpinevision, S.A.S.20211—
+6K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+6K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+6K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+6K200316UNiD IB3D ALIFMedicrea International SA20200—
+6K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+6K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+6K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+6K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+6K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+6K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+6K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+6K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+6K192897icotec Cervical CageIcotec AG20201—
+6K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+6K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+6K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+6K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+6K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+6K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+6K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+6K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+6K190680Favo S-TlifSilony Medical GmbH20190—
+6K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+6K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+6K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+6K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+6K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+6K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+6K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+6K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+6K172941CASCADIA Interbody SystemK2m201852—
+6K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+6K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+6K171704CAPRI Corpectomy Cage SystemK2m201710—
+6K171425Concorde LiftMedos International SARL201782
+6K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+7K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+7K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+7K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+7K261279DeltaNEC Interbody SystemNexus Spine20260—
+7K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+7K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+7K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+7K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+7K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+7K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+7K250769Dakota LP SystemPrecision Spine, Inc.20250—
+7K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+7K252742Navigated InstrumentsTyber Medical, LLC20251—
+7K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+7K253331PressON Spinal Fixation SystemNexus Spine20250—
+7K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+7K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+7K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+7K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+7K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+7K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+7K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+7K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+7K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+7K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+7K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+7K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+7K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+7K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+7K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+7K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+7K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+7K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+7K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+7K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+7K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+7K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+7K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+7K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+7K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+7K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+7K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+7K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+7K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+7K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+7K230026SqualeImplanet, S.A.20230—
+7K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+7K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—