510(k) Report

Devices descending from K083393

292 later devices reach Xia 3 Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+3K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151
+3K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+3K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+3K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+3K151216Everest Spinal SystemK2m, Inc.201511—
+3K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+3K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+3K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+3K132303Implanet Spine SystemImplanet, S.A.201315—
+3K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+3K131878Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc.20138—
+3K130291S4 Spinal SystemAesculap Implant System, Inc.201344—
+3K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+3K120838Synthes Matrix SystemSynthes Spine201216—
+3K111634Xenon (TM) Pedicle Screw SystemAlphatec Spine, Inc.20120—
+3K112759Apclo Pedicle Screw SystemsAtlas Spine, Inc.20112—
+4K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+4K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+4K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K252461Swedge™ Pedicle Screw Fixation System Bezier RodSpinal Resources, Inc.20260—
+4K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+4K253249TriALTIS™ Spine SystemMedos International SARL20251—
+4K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+4K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+4K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+4K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+4K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+4K240392JAZZ Spinal SystemImplanet20241—
+4K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+4K233300POWEReam 1/4 DriveStryker Instruments20231—
+4K231515MySpine Cervical GuidesMedacta International S.A.20230—
+4K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+4K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+4K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+4K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+4K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+4K231483MySpine Unilateral GuidesMedacta International S.A.20230—
+4K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+4K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+4K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+4K220025ARx® Spinal SystemLife Spine, Inc.20220—
+4K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+4K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+4K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+4K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+4K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+4K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+4K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+4K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+4K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+4K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+4K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+4K200794AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20208—
+4K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+4K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+4K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+4K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+4K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+4K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A.20195—
+4K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+4K182240PASS LP Spinal SystemMedicrea International SA20182—
+4K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+4K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+4K181978Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20180—
+4K173508Everest Spinal SystemK2m20189—
+4K170964Zenius Spinal SystemMedyssey USA, Inc.20170—
+4K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+4K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+4K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20167—
+4K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A.20161—
+4K153404Zavation Spinal SystemZavation, LLC20161—
+4K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+4K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+4K151974Polaris Spinal SystemBiomet Spine201516—
+4K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+4K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+4K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+4K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+4K141850Flospine Pedicle Screw SystemFlospine20140—
+4K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+5K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+5K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+5K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K252437JAZZ Spinal SystemImplanet20250—
+5K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+5K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K240526POWEReam Xia/SerratoStryker Instruments20240—
+5K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—