510(k) Report

Devices descending from K082732

710 later devices reach Modification to: Capstone Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+7K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+7K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+7K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+7K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+7K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+7K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+7K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+7K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+7K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+7K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+7K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+7K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+7K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+7K1803473d CageFims Co., Ltd.20190—
+7K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+7K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+7K190680Favo S-TlifSilony Medical GmbH20190—
+7K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+7K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+7K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+7K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+7K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+8K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+8K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+8K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+8K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+8K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+8K261067BEE PLIF CageNGMedical GmbH20260—
+8K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+8K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+8K253545Vulcan Spinal SystemK2m, Inc.20260—
+8K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+8K250769Dakota LP SystemPrecision Spine, Inc.20250—
+8K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+8K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+8K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+8K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+8K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+8K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+8K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+8K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+8K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+8K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+8K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+8K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+8K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+8K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+8K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+8K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+8K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+8K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+8K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+8K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+8K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+8K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+8K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+8K230989Rod Registration FrameNu Vasive, Incorporated20230—
+8K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+8K223418DeGen Impulse AM™ SystemDegen Medical20236—
+8K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+8K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+8K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+8K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+8K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+8K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+8K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+8K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+8K212358Romero Cervical CageSpineup, Inc.20226—
+8K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+8K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+8K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+8K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+8K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+8K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+8K211413BEE PLIF CageNGMedical GmbH20211—
+8K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+8K210728CONDUIT InstrumentsMedos International SARL20215—
+8K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+8K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+8K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+8K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+9K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+9K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+9K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+9K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+9K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+9K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+9K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+9K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+9K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+9K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+9K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+9K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—