510(k) Report

Devices descending from K984251

372 later devices reach Xia Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K231479TriALTIS Spine SystemMedos International SARL20238—
+6K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+6K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+6K222789VADER® Pedicle System, G21 CementIcotec AG202352
+6K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20224—
+6K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+6K223294SpineJack® Expansion KitStryker Instruments20221—
+6K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+6K200794AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20208—
+6K190163ALARA Neuro Access KitSurGenTec, LLC20192—
+6K190762The JASPER Spinal Fixation System IIGbs Commonwealth Co., Ltd.20191—
+6K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20193—
+6K190376PASS LP Spinal SystemMedicrea International SA201915
+6K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+6K180376K2M Patient Specific RodsK2m, Inc.20182—
+6K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd.201533—
+6K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+6K121568Dali Spinal Fixation SystemAccel Spine20121—
+6K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd.2012111—
+6K111957Polaris Spinal SystemBiomet Spine (Ebi, LLC)201176—
+7K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+7K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+7K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+7K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+7K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+7K250637VCFix Spinal SystemAmber Implants20250—
+7K243945ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20250—
+7K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K243249TriALTIS™ Spine SystemMedos International SARL20250—
+7K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+7K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20241—
+7K232628VADER® Pedicle SystemIcotec AG20241—
+7K233684TriALTIS™ Spine SystemMedos International SARL20234—
+7K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+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—
+7K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+7K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+7K200790LnK Spinal Fixation System, OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.20205—
+7K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20192—
+7K173645JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd.20183—
+7K171813OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd.201730—
+7K151974Polaris Spinal SystemBiomet Spine201516—
+7K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+7K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.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—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+8K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+8K242042TriALTIS™ Spine SystemMedos International SARL20241—
+8K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+8K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+8K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+8K183168OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.201823—
+8K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+8K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+8K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+8K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+8K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+9K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, 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—
+9K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+9K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+9K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+10K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+10K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—