510(k) Report

Devices descending from K052069

549 later devices reach Protex Stabilization System with Additional Componentes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+6K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+6K171813OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd.201730—
+6K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+6K162824Z-Span Plate SystemZavation, LLC20172—
+6K161028K2M Growing Spine SystemK2m, Inc.20163—
+6K151977icotec Pedicle SystemIcotec AG201630—
+6K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+6K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+6K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+6K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+6K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+6K133402K2M Modular HooksK2m, Inc.20140—
+6K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+6K131250Tiger Spine SystemCorelink, LLC201340—
+6K131785Pagoda Pedicle Screw SystemOrtho Development Corp.20136—
+6K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+7K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC20260—
+7K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+7K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+7K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+7K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+7K262094E3D™-C Interbody SystemEvolution Spine20260—
+7K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+7K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+7K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+7K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+7K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+7K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+7K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+7K260038E3D™-C Interbody SystemEvolution Spine20261—
+7K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+7K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+7K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+7K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+7K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+7K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+7K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+7K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+7K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+7K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+7K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+7K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+7K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+7K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+7K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+7K232432E3D™-A Interbody SystemEvolution Spine20248—
+7K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+7K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+7K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+7K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+7K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+7K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+7K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+7K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+7K222789VADER® Pedicle System, G21 CementIcotec AG202352
+7K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+7K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+7K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+7K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+7K203023Pisces Spinal SystemOrtho Development Corporation20210—
+7K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+7K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+7K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+7K201006K2M Navigation InstrumentsK2m, Inc.20200—
+7K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+7K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+7K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.201910—
+7K183168OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.201823—
+7K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+7K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+7K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+7K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+7K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+7K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+7K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+7K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+7K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+7K133369Tiger Spine SystemCorelink, LLC201429—
+8K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+8K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+8K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+8K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+8K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+8K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+8K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+8K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+8K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+8K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+8K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+8K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+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—
+8K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+8K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+8K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+8K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+8K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+8K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—