510(k) Report

Devices descending from K103111

343 later devices reach Forza Spacer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+4K203444BEE HA CageNGMedical GmbH20211—
+4K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+4K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+4K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+4K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+4K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+4K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+4K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+4K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+4K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+4K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+4K191134IB3D AlifMedicrea International SA20191—
+4K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+4K190680Favo S-TlifSilony Medical GmbH20190—
+4K182608Oyster ACIF CageSilony Medical GmbH20190—
+4K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+4K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+4K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+4K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+4K172816TiGer Shark™ SystemChoicespine, LP201859—
+4K172419Velofix™ TLIF CageU&I Corporation20172—
+4K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+5K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+5K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+5K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+5K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+5K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+5K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+5K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+5K250560BEE HANGMedical GmbH20250—
+5K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+5K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+5K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+5K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+5K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+5K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+5K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+5K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+5K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+5K241846E3D™-C Interbody SystemEvolution Spine20246—
+5K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+5K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+5K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+5K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+5K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+5K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+5K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+5K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+5K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+5K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+5K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+5K230329F3D Interbody SystemCorelink, LLC20230—
+5K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+5K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+5K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+5K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+5K213417Ghost Spacer SystemLife Spine, Inc.20220—
+5K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+5K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+5K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+5K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+5K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+5K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+5K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+5K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+5K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+5K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+5K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+5K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+5K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+5K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+5K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+5K210728CONDUIT InstrumentsMedos International SARL20215—
+5K201671A-Link ZAcuity Surgical Devices, LLC202125—
+5K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+5K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+5K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+5K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+5K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+5K200316UNiD IB3D ALIFMedicrea International SA20200—
+5K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+5K183243Velofix TLIF CageU&I Corporation20190—
+5K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+5K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+5K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+5K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+5K181829Velofix TLIF CageU&I Corporation20181—
+5K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+6K262094E3D™-C Interbody SystemEvolution Spine20260—
+6K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+6K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+6K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+6K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+6K253260ORIO-3D Cage SystemSpineCraft20260—
+6K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+6K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—