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
+7K223251Hexanium PLIFSpinevision, S.A.S.20220—
+7K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+7K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+7K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+7K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+7K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+7K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+7K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+7K203003Pantheon IBFDPantheon Spinal20210—
+7K202637F3D Corpectomy SystemCorelink, LLC20201—
+7K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+7K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+7K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+7K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+7K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+7K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+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—
+7K173537Concorde Lift™Medos International SARL20181—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K253545Vulcan Spinal SystemK2m, Inc.20260—
+8K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+8K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K252322SIros-X SystemGenesys Spine20250—
+8K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+8K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+8K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+8K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+8K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+8K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+8K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+8K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+8K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+8K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+8K221578Hexanium ACIFSpinevision, S.A.S.20224—
+8K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+8K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+8K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+8K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+8K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+8K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+9K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+9K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+9K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+9K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+9K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+9K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+9K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+9K211306LabyrinthZavation Medical Products, LLC20213—
+10K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+10K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—