510(k) Report

Devices descending from K022949

867 later devices reach Synthes Uss, Click'x, Uss Vas, Dual-Opening Uss and Small Stature Uss through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+7K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+7K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+7K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+7K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+7K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+7K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+7K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+7K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+7K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+7K241846E3D™-C Interbody SystemEvolution Spine20246—
+7K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+7K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+7K240368E3D™-A Interbody SystemEvolution Spine20247—
+7K240526POWEReam Xia/SerratoStryker Instruments20240—
+7K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+7K234051Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion…Spinal Simplicity, LLC20241—
+7K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+7K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+7K231658VEOS Spinal Fixation SystemSpineway20230—
+7K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+7K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+7K231479TriALTIS Spine SystemMedos International SARL20238—
+7K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+7K231840CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20230—
+7K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20231—
+7K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+7K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+7K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+7K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC20230—
+7K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+7K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+7K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+7K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+7K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc.20232—
+7K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+7K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+7K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+7K222628Life Spine ALIF Buttress Plate SystemLife Spine, Inc.20220—
+7K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+7K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+7K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+7K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc.20226—
+7K211981KHEIRON® Spinal Fixation SystemS.M.A.I.O20228—
+7K213659LigaPASS™ 2.0 Ligament Augmentation SystemMedicrea International SA20222—
+7K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+7K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+7K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+7K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+7K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+7K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+7K202624Z-Span Plate SystemZavation Medical Products, LLC20201—
+7K202771CD Horizon Spinal SystemMedtronic202021—
+7K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+7K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+7K200956NuVasive Thoracolumbar PlatesNu Vasive, Incorporated20200—
+7K200896Solstice CCILife Spine, Inc.20200—
+7K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+7K193129Yukon OCT Spinal SystemK2m, Inc.202001
+7K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+7K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+7K183381Navigation Enabled InstrumentsStryker20191—
+7K190418NuVasive® VersaTie® SystemNu Vasive, Incorporated20190—
+7K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+7K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+7K173506LigaPASSMedicrea International SA20189—
+7K162824Z-Span Plate SystemZavation, LLC20172—
+7K160640PASS XS Spinal SystemMedicrea International SA20160—
+7K161627PASS LP Spinal SystemMedicrea International SA20167—
+7K153413PASS LP Spinal SystemMedicrea International SA20160—
+7K151977icotec Pedicle SystemIcotec AG201630—
+7K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+7K131250Tiger Spine SystemCorelink, LLC201340—
+7K131785Pagoda Pedicle Screw SystemOrtho Development Corp.20136—
+8K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC20260—
+8K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+8K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+8K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+8K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+8K262094E3D™-C Interbody SystemEvolution Spine20260—
+8K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+8K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+8K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+8K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+8K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+8K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+8K260038E3D™-C Interbody SystemEvolution Spine20261—
+8K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+8K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+8K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+8K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K253250Minuteman® G6 MIS Fusion PlateSpinal Simplicity, LLC20250—
+8K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+8K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+8K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+8K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+8K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—