510(k) Report

Devices descending from K024096

466 later devices reach Optima, Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K220025ARx® Spinal SystemLife Spine, Inc.20220—
+5K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+5K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+5K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+5K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+5K210549ARx Spinal SystemLife Spine, Inc.20211—
+5K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+5K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+5K201287Impulse Interbody Fusion SystemDegen Medical20208—
+5K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+5K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+5K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+5K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+5K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+5K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+5K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+5K200303Reform Pedicle Screw SystemPrecision Spine202010—
+5K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+5K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+5K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+5K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+5K183168OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.201823—
+5K183117PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.20184—
+5K181883FIREFLY® Midline Navigation GuideMighty Oak Medical, Inc.20184—
+5K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20185—
+5K181188EVEREST Spinal SystemK2m, Inc.20186—
+5K172115Navigated Instrument SystemOrthofix, Inc.20184—
+5K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+5K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+5K171321K2M Navigation InstrumentsK2m201711
+5K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+5K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+5K170647Connector SystemOrthofix, Inc.201718—
+5K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+5K161842Overwatch Spine SystemAmendia, Inc.201661
+5K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+5K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+5K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+5K142360Everest Spinal SystemK2m, Inc.201522—
+5K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+5K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+6K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.20260—
+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—
+6K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+6K253472FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical20260—
+6K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+6K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+6K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+6K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+6K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+6K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+6K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+6K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+6K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+6K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+6K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K240368E3D™-A Interbody SystemEvolution Spine20247—
+6K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+6K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+6K232432E3D™-A Interbody SystemEvolution Spine20248—
+6K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+6K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+6K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+6K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+6K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+6K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+6K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+6K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+6K223418DeGen Impulse AM™ SystemDegen Medical20236—
+6K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+6K213417Ghost Spacer SystemLife Spine, Inc.20220—
+6K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+6K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+6K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+6K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+6K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+6K212358Romero Cervical CageSpineup, Inc.20226—
+6K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+6K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+6K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+6K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+6K201006K2M Navigation InstrumentsK2m, Inc.20200—
+6K200070ARx Spinal SystemLife Spine, Inc.20209—
+6K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+6K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+6K191575ARx Spinal SystemLife Spine, Inc.201910—
+6K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+6K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+6K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+6K182470Plateau Spacer SystemLife Spine20180—
+6K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+6K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—