510(k) Report

Devices descending from K992168

547 later devices reach Moss Miami 6.35MM Polyaxial Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+5K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+5K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+5K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+5K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+5K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+5K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+5K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+5K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+5K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+5K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+5K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+5K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+5K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+5K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+5K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+5K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+5K222105RESPONSE 5.5/6.0 Cannulated Screw SystemOrthoPediatrics Corp.20230—
+5K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+5K222789VADER® Pedicle System, G21 CementIcotec AG202352
+5K222774iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.202220—
+5K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+5K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+5K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+5K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+5K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+5K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+5K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+5K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+5K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+5K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+5K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+5K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+5K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+5K203023Pisces Spinal SystemOrtho Development Corporation20210—
+5K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+5K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+5K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+5K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+5K201287Impulse Interbody Fusion SystemDegen Medical20208—
+5K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+5K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+5K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+5K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+5K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+5K201006K2M Navigation InstrumentsK2m, Inc.20200—
+5K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+5K200322Altus Spine Pedicle Screw SystemAltus Partners, LLC20204—
+5K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+5K200070ARx Spinal SystemLife Spine, Inc.20209—
+5K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+5K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+5K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+5K191575ARx Spinal SystemLife Spine, Inc.201910—
+5K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+5K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+5K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+5K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+5K180376K2M Patient Specific RodsK2m, Inc.20182—
+5K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+5K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+5K172115Navigated Instrument SystemOrthofix, Inc.20184—
+5K180156SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation SystemGlobus Medical, Inc.20185—
+5K173508Everest Spinal SystemK2m20189—
+5K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc.20170—
+5K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+5K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+5K170647Connector SystemOrthofix, Inc.201718—
+5K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+5K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+5K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+5K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+5K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+5K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+5K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+5K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+5K151813Sniper Spine SystemSpine Wave, Inc.20159—
+5K143110GALAXY MIS Screw SystemBm Korea20152—
+5K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+5K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+5K133402K2M Modular HooksK2m, Inc.20140—
+5K140529Everest Spinal SystemK2m, LLC201431—
+5K132361Everest Spinal SystemK2m, Inc.201334—
+5K123164Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.201336
+5K111115Captiva Spine Caplox II Spinal Fixation SystemCaptiva Spine, Inc.201116—
+5K100122Modification to Capsure PS SystemSpine Wave, Inc.20102—
+5K083743Capsure PS SystemSpine Wave, Inc.20093—
+5K080767Conquest Spinal SystemLife Spine200821—
+6K262094E3D™-C Interbody SystemEvolution Spine20260—
+6K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+6K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+6K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+6K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+6K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—