510(k) Report

Devices descending from K050461

742 later devices reach Xia 4.5 Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+4K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+4K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+4K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K220025ARx® Spinal SystemLife Spine, Inc.20220—
+4K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+4K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+4K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+4K191726mont blanc & mont blanc MIS Spinal SystemsSpineway SA20190—
+4K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+4K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+4K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+4K182240PASS LP Spinal SystemMedicrea International SA20182—
+4K180220SAGICO OSI Spinal System by OsimplantSpinal Analytics & Geometrical Implant Co, LLC20181—
+4K173508Everest Spinal SystemK2m20189—
+4K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+4K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+4K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+4K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+4K150294DPZ Pedicular Fixation SystemOsteomed Implantes, Ltda20150—
+4K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd.201533—
+4K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+4K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+4K122571Malibu Spinal System with the Daytona Deformity SystemSeaspine, Inc.201262—
+4K121568Dali Spinal Fixation SystemAccel Spine20121—
+4K113666Xia 3 Spinal SystemStryker Spine2012251—
+4K120714Picasso Mis Spinal Fixation SystemAccel Spine20122—
+4K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd.2012111—
+4K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+4K112643Focus Mis SystemL&K BIOMED Co., Ltd.201226—
+4K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+4K092631Mantis Redux Spinal SystemStryker Spine2009110—
+4K091291Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium RodStryker Spine2009169—
+4K083393Xia 3 Spinal SystemStryker Spine20092921
+4K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+4K090230Expedium Spine SystemDepuy Spine, Inc.2009462—
+4K082353Mercury Spinal SystemSpinal Elements, Inc.200911—
+4K083230Mercury Spinal SystemSpinal Elements, Inc.200811—
+4K082942Modfication to: Expedium Spine SystemDepuy Spine, Inc.2008518—
+4K082608Radius Spinal System, Vitallium Rod #486613601Stryker Spine2008200—
+4K072605Malibu Spinal SystemSeaspine, Inc.200767—
+4K072426Atlas Spine Pedicle Screw SystemAtlas Spine, LLC200751
+4K070295Single Planar Multi Axial (Spma) Pedicle Screw SystemTrinity Orthopedics, LLC20070—
+4K062670Vertiflex Spinal Screw SystemVertiflex (Tm), Incorporated200712—
+4K063428Xia Stainless Steel Spinal SystemStryker Spine2006204—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+5K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+5K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+5K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+5K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+5K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+5K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+5K252322SIros-X SystemGenesys Spine20250—
+5K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+5K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+5K250092HC Biologics Osteopoint Spinal Fixation SystemHC Biologics, LLC20250—
+5K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+5K240526POWEReam Xia/SerratoStryker Instruments20240—
+5K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+5K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+5K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+5K231479TriALTIS Spine SystemMedos International SARL20238—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+5K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+5K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20224—
+5K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+5K222110Mariner RDX SystemSeaSpine Orthopedics Corporation202282
+5K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+5K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+5K211606Mariner Deformity SystemSeaSpine Orthopedics Corporation2021471
+5K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+5K200790LnK Spinal Fixation System, OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.20205—
+5K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+5K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+5K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+5K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+5K190376PASS LP Spinal SystemMedicrea International SA201915
+5K180337EUROPA Pedicle Screw SystemMiRus, LLC20196—
+5K182970EUROPA™ Pedicle Screw SystemMiRus, LLC20192—
+5K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+5K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+5K173645JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd.20183—
+5K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+5K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+5K172967Mercury® Spinal SystemSpinal Elements, Inc.20185—
+5K180376K2M Patient Specific RodsK2m, Inc.20182—
+5K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+5K180176SeaSpine NewPort Spinal SystemSeaSpine Orthopedics Corporation20180—
+5K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+5K173882SeaSpine Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation2018561
+5K171813OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd.201730—
+5K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+5K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+5K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+5K161535SeaSpine® NewPort™ Spinal SystemSeaSpine Orthopedics Corporation201614—