510(k) Report

Devices descending from K063158

477 later devices reach Synthes Antegra System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K241846E3D™-C Interbody SystemEvolution Spine20246—
+8K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+8K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+8K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+8K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+8K240368E3D™-A Interbody SystemEvolution Spine20247—
+8K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+8K240442MagnetOs PuttyKuros Biosciences B.V20243—
+8K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+8K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+8K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+8K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+8K240458Synthetic Bone PuttyVentris Medical20242—
+8K240459Cerament Bone Void FillerBonesupport AB20240—
+8K232347MagnetOs GranulesKuros Biosciences B.V20242—
+8K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+8K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+8K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+8K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+8K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+8K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+8K232315Catalyst Bone Void FillerOssdsign AB20237—
+8K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+8K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+8K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+8K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+8K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+8K230583Tryptik TiSpineart SA20231—
+8K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+8K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+8K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+8K223494CD Horizon Spinal SystemMedtronic202317—
+8K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+8K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+8K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+8K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+8K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+8K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+8K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+8K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+8K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+8K221172FOCUS Interbody SystemOc Medical Devices20220—
+8K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+8K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+8K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+8K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+8K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+8K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+8K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+8K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+8K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+8K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+8K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+8K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+8K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+8K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+8K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+8K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+8K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+8K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+8K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+8K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+8K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+8K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+8K201671A-Link ZAcuity Surgical Devices, LLC202125—
+8K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+8K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+8K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+8K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+8K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+8K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+8K201585Monterey AL Interbody SystemStryker Corporation202044
+8K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+8K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+8K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+8K192897icotec Cervical CageIcotec AG20201—
+8K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+8K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+8K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+8K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+8K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+8K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+8K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+8K183064TxTi IBF SystemInnovasis, Inc.2019481
+8K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+8K183092Kuros TLIF CageKuros Biosciences B.V20190—
+8K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+8K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+8K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+8K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+8K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+8K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+9K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+9K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+9K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+9K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+9K262094E3D™-C Interbody SystemEvolution Spine20260—
+9K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+9K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+9K261279DeltaNEC Interbody SystemNexus Spine20260—