510(k) Report

Devices descending from K061854

216 later devices reach Xia Titanium Spinal System and Xia Stainless Steel Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+5K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+6K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+6K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+6K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+6K253249TriALTIS™ Spine SystemMedos International SARL20251—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+6K240526POWEReam Xia/SerratoStryker Instruments20240—
+6K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+6K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+6K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+6K223294SpineJack® Expansion KitStryker Instruments20221—
+6K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+6K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+6K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+6K220025ARx® Spinal SystemLife Spine, Inc.20220—
+6K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+6K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+6K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+6K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+6K200794AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20208—
+6K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+6K190163ALARA Neuro Access KitSurGenTec, LLC20192—
+6K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+6K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20193—
+6K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+6K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+6K182240PASS LP Spinal SystemMedicrea International SA20182—
+6K180433Ennovate®Aesculap Implant Systems, LLC201811
+6K173508Everest Spinal SystemK2m20189—
+6K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+6K151974Polaris Spinal SystemBiomet Spine201516—
+6K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+6K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+6K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+6K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+7K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+7K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+7K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+7K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+7K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+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—
+7K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+7K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+7K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20241—
+7K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+7K231479TriALTIS Spine SystemMedos International SARL20238—
+7K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+7K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+7K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+7K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+7K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+7K200303Reform Pedicle Screw SystemPrecision Spine202010—
+7K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+7K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20192—
+7K190376PASS LP Spinal SystemMedicrea International SA201915
+7K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+7K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+7K180376K2M Patient Specific RodsK2m, Inc.20182—
+7K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+7K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+7K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+8K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+8K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+8K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+8K243249TriALTIS™ Spine SystemMedos International SARL20250—
+8K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+8K233684TriALTIS™ Spine SystemMedos International SARL20234—
+8K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+8K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+8K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+8K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+8K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+8K191575ARx Spinal SystemLife Spine, Inc.201910—
+8K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+9K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+9K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+9K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+9K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+9K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+9K242042TriALTIS™ Spine SystemMedos International SARL20241—
+9K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+9K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+9K233256Robotic Integration InstrumentsDePuy Synthes20240—
+9K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+9K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+9K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+9K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+9K200070ARx Spinal SystemLife Spine, Inc.20209—