510(k) Report

Devices descending from K043473

289 later devices reach Modification to Xia Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+6K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+6K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K252437JAZZ Spinal SystemImplanet20250—
+6K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+6K250637VCFix Spinal SystemAmber Implants20250—
+6K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+6K243945ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20250—
+6K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+6K243249TriALTIS™ Spine SystemMedos International SARL20250—
+6K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+6K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20241—
+6K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+6K233684TriALTIS™ Spine SystemMedos International SARL20234—
+6K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+6K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+6K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+6K222789VADER® Pedicle System, G21 CementIcotec AG202352
+6K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+6K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+6K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+6K200794AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20208—
+6K201240Mariner Cap SystemSeaSpine Orthopedics Corporation20200—
+6K200303Reform Pedicle Screw SystemPrecision Spine202010—
+6K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20192—
+6K191217Jazz PFImplanet, S.A.20190—
+6K190762The JASPER Spinal Fixation System IIGbs Commonwealth Co., Ltd.20191—
+6K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+6K183168OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.201823—
+6K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+6K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+6K171881JAZZ Passer BandImplanet, S.A.20170—
+6K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+6K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+6K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+6K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+6K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+7K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+7K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+7K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+7K242042TriALTIS™ Spine SystemMedos International SARL20241—
+7K232628VADER® Pedicle SystemIcotec AG20241—
+7K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+7K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+7K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+7K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+7K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+7K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+7K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+7K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+7K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+7K191575ARx Spinal SystemLife Spine, Inc.201910—
+7K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+7K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+8K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+8K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+8K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+8K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+8K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+8K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+8K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+8K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+8K233256Robotic Integration InstrumentsDePuy Synthes20240—
+8K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+8K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+8K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+8K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+8K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+8K200070ARx Spinal SystemLife Spine, Inc.20209—
+9K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+9K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+9K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+9K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+9K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+9K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+9K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+10K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+10K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+11K254274ARx® SAI Implant SystemLife Spine, Inc.20260—