510(k) Report

Devices descending from K041888

1,586 later devices reach Curved Peek Tetris Spinal Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+5K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+5K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+5K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+5K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+5K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+5K243670Idys® LIFClariance20240—
+5K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+5K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+5K242589Scarlet® AL-TSpineart SA20240—
+5K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+5K242267Gemini Medical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+5K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+5K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+5K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+5K240368E3D™-A Interbody SystemEvolution Spine20247—
+5K240699SCARLET® AC-TiSpineart SA20240—
+5K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+5K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+5K233744Curiteva Porous PEEK Lumbar Interbody Fusion SystemCuriteva, Inc.20242—
+5K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+5K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+5K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+5K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+5K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+5K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+5K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+5K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+5K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+5K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+5K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+5K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+5K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+5K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+5K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+5K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+5K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+5K230329F3D Interbody SystemCorelink, LLC20230—
+5K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+5K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+5K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+5K230808PEEK SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20230—
+5K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+5K230583Tryptik TiSpineart SA20231—
+5K223043The Integrity Spine Core SystemIntegrity Spine20230—
+5K223776PEEK Spinal Infusion CageChangzhou Geasure Medical Apparatus and Instruments Co., Ltd.20230—
+5K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+5K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+5K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+5K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+5K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+5K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+5K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+5K221545MectaLIF Anterior ExtensionMedacta International S.A.202226
+5K221172FOCUS Interbody SystemOc Medical Devices20220—
+5K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+5K221844TDM Lumbar Interbody Fusion Cage SystemTdm Co., Ltd.20221—
+5K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+5K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+5K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+5K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+5K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+5K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+5K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+5K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+5K212126MediExpand Cervical Expandable VBR SystemCmf Medicon Surgical, Inc.20220—
+5K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+5K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+5K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+5K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+5K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+5K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+5K210573Velofix SA Cervical CageU&I Corporation20211—
+5K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+5K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+5K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+5K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+5K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+5K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+5K211413BEE PLIF CageNGMedical GmbH20211—
+5K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+5K201671A-Link ZAcuity Surgical Devices, LLC202125—
+5K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+5K202032Idys LLIF 3DTiClariance, Sas20210—
+5K203444BEE HA CageNGMedical GmbH20211—
+5K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+5K210359Hexanium TLIFSpinevision, S.A.S.20211—
+5K202380Born PT-LIF Cage HASpineworxx AG20210—
+5K200429BEE CagesNGMedical GmbH202111—
+5K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+5K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+5K201287Impulse Interbody Fusion SystemDegen Medical20208—
+5K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+5K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+5K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+5K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+5K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+5K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—