510(k) Report

Devices descending from K012027

206 later devices reach Modification to Xia Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K162367Erisma® LP MISClariance, Sas20162—
+7K151974Polaris Spinal SystemBiomet Spine201516—
+7K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+7K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+7K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+7K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+7K140400ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20149—
+7K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+7K103292Trio Trauma Spinal SystemStryker Corporation201185—
+8K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+8K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+8K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+8K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+8K243249TriALTIS™ Spine SystemMedos International SARL20250—
+8K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+8K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+8K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+8K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+8K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+8K233684TriALTIS™ Spine SystemMedos International SARL20234—
+8K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+8K230974NIDO™ Pedicle Screw SystemKalitec Medical20230—
+8K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+8K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+8K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+8K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+8K200303Reform Pedicle Screw SystemPrecision Spine202010—
+8K191810Curiteva Pedicle Screw SystemCuriteva, Inc.20190—
+8K190762The JASPER Spinal Fixation System IIGbs Commonwealth Co., Ltd.20191—
+8K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.201910—
+8K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+8K183168OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.201823—
+8K182059Prase MIS Spinal SystemGbs Commonwealth Co., Ltd.20182—
+8K180433Ennovate®Aesculap Implant Systems, LLC201811
+8K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+8K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+8K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+8K171807ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20177—
+8K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+8K142438Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.)20154—
+8K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+8K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+9K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+9K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+9K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+9K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+9K242042TriALTIS™ Spine SystemMedos International SARL20241—
+9K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+9K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+9K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+9K223294SpineJack® Expansion KitStryker Instruments20221—
+9K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+9K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+9K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+9K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+9K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+9K200794AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20208—
+9K191575ARx Spinal SystemLife Spine, Inc.201910—
+9K190163ALARA Neuro Access KitSurGenTec, LLC20192—
+9K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20193—
+9K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+9K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+10K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+10K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+10K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+10K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+10K250637VCFix Spinal SystemAmber Implants20250—
+10K243945ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20250—
+10K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+10K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+10K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20241—
+10K233256Robotic Integration InstrumentsDePuy Synthes20240—
+10K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+10K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+10K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+10K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+10K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+10K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+10K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+10K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+10K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+10K200070ARx Spinal SystemLife Spine, Inc.20209—
+10K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+10K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20192—
+11K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+11K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+11K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+11K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+11K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+11K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+11K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+11K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+11K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+12K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+12K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+12K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+12K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+12K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+12K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+12K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—