510(k) Report

Devices descending from K012870

908 later devices reach Xia Stainless Steel System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K171813OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd.201730—
+4K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+4K170964Zenius Spinal SystemMedyssey USA, Inc.20170—
+4K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC20176—
+4K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+4K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+4K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+4K162367Erisma® LP MISClariance, Sas20162—
+4K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+4K162143FixxSure® X-LinkInnovasis, Inc.20160—
+4K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+4K151458Double Medical Universal Spine SystemDouble Medical Technology, Inc.20160—
+4K161914Genesys Spine TiLock Cortical Spinal SystemGenesys Spine20161—
+4K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+4K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+4K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+4K150684WASTON General Spinal SystemChangzhou Waston Medical Appliance Co., Ltd.20150—
+4K152039Genesys Spine TiLock2 Spinal SystemGenesys Spine20157—
+4K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+4K151727Everest Spinal SystemK2m, Inc.201511—
+4K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+4K151216Everest Spinal SystemK2m, Inc.201511—
+4K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+4K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+4K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+4K150294DPZ Pedicular Fixation SystemOsteomed Implantes, Ltda20150—
+4K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+4K150417Astra Spine SystemSpinecraft, LLC201521—
+4K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+4K143377PedFuse Pedicle Screw SystemSpinefrontier, Inc.20150—
+4K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+4K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+4K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+4K134011General Spinal SystemChangzhou Dean Medical Instrument Co, Ltd.20140—
+4K140260Skyhawk Lateral Plate SystemOrthofix, Inc.201414—
+4K140400ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20149—
+4K140229General Spinal SystemTianjin Walkman Biomaterial Co., Ltd.20140—
+4K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+4K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+4K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+4K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+4K130302Spinevision Lumis Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision…Spinevision S.A.20134—
+4K131343Reform Pedicle Screw SystemSpinal USA201331—
+4K130279Reform Pedicle Screw SystemSpinal USA201331—
+4K123373Nautilus Spinal SystemLife Spine201317—
+4K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+4K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+4K122571Malibu Spinal System with the Daytona Deformity SystemSeaspine, Inc.201262—
+4K113666Xia 3 Spinal SystemStryker Spine2012251—
+4K120714Picasso Mis Spinal Fixation SystemAccel Spine20122—
+4K111634Xenon (TM) Pedicle Screw SystemAlphatec Spine, Inc.20120—
+4K112643Focus Mis SystemL&K BIOMED Co., Ltd.201226—
+4K111690Devine Spinal SystemChangzhou Orthmed Medical Instrument Co., Ltd.20113—
+4K112759Apclo Pedicle Screw SystemsAtlas Spine, Inc.20112—
+4K111957Polaris Spinal SystemBiomet Spine (Ebi, LLC)201176—
+4K110906Apex Spine SystemSpinecraft, LLC2011103—
+4K090320Conquest Spinal SystemLife Spine20092—
+4K083393Xia 3 Spinal SystemStryker Spine20092921
+4K090230Expedium Spine SystemDepuy Spine, Inc.2009462—
+4K082942Modfication to: Expedium Spine SystemDepuy Spine, Inc.2008518—
+4K072605Malibu Spinal SystemSeaspine, Inc.200767—
+4K072426Atlas Spine Pedicle Screw SystemAtlas Spine, LLC200751
+4K062670Vertiflex Spinal Screw SystemVertiflex (Tm), Incorporated200712—
+5K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+5K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+5K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+5K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+5K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+5K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+5K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+5K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+5K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+5K260015ANTERIS Thoracolumbar Plate SystemSpineCraft20260—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K252461Swedge™ Pedicle Screw Fixation System Bezier RodSpinal Resources, Inc.20260—
+5K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+5K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+5K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K252322SIros-X SystemGenesys Spine20250—
+5K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K253249TriALTIS™ Spine SystemMedos International SARL20251—
+5K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+5K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+5K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+5K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+5K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+5K250092HC Biologics Osteopoint Spinal Fixation SystemHC Biologics, LLC20250—
+5K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+5K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+5K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+5K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+5K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+5K233256Robotic Integration InstrumentsDePuy Synthes20240—
+5K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+5K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+5K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—