510(k) Report

Devices descending from K901587

580 later devices reach TSRH Sacral L-Connector through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K001080Spine System EvolutionAesculap, Inc.200062—
+3K993503Haider-Ucr Spinal SystemInternational Advanced Medical Enterprises, Inc.2000176—
+3K9942885.0MM Spinal ScrewsOrtho Tec, LLC20000—
+3K993926Omniaxial ConnectorOrtho Tec, LLC19990—
+3K991326Isobar Semi-Rigid Spinal SystemScien'Tx USA, Inc.19992—
+4K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+4K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+4K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+4K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+4K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+4K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+4K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20224—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+4K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+4K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+4K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+4K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+4K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+4K200794AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20208—
+4K200303Reform Pedicle Screw SystemPrecision Spine202010—
+4K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+4K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+4K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+4K180433Ennovate®Aesculap Implant Systems, LLC201811
+4K180156SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation SystemGlobus Medical, Inc.20185—
+4K173126Arisstos™ Spinal SystemIngenium Spine20171—
+4K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+4K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+4K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+4K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+4K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+4K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+4K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+4K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+4K151977icotec Pedicle SystemIcotec AG201630—
+4K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20165—
+4K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+4K151727Everest Spinal SystemK2m, Inc.201511—
+4K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+4K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+4K150185Mont Blanc Spinal SystemSpineway20154—
+4K141044M.U.S.T. ExtensionMedacta International201416—
+4K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+4K140238Excella Iii-D Spinal Deformity SystemInnovasis, Inc.201432
+4K133369Tiger Spine SystemCorelink, LLC201429—
+4K132878M.U.S.T. ExtensionMedacta International201328—
+4K132603Apex Spine SystemSpinecraft, LLC201325—
+4K131250Tiger Spine SystemCorelink, LLC201340—
+4K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+4K123552Instinct Java SystemZimmer Spine201301
+4K122592Instinct Java SystemZimmer Spine201301
+4K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+4K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+4K120491DSS Stabilization System-RigidParadigm Spine, LLC20120—
+4K120696Tiger Spine SystemCorelink, LLC201241—
+4K113058Tiger Spine SystemCorelink, LLC201281—
+4K113625DSS Stabilization SystemParadigm Spine, LLC20121—
+4K113270Instinct Java SystemZimmer Spine201121
+4K112551S4 Spinal SystemAesculap Implant System, Inc.201161—
+4K111957Polaris Spinal SystemBiomet Spine (Ebi, LLC)201176—
+4K102248Excella II Spinal System Model EC2-00Innovasis, Inc.201043
+4K101083DSS Stabilization SystemParadigm Spine, LLC20102—
+4K092624Firebird Spinal Fixation SystemBlackstone Medical, Inc.20091301
+4K091944Modification to: DSS Stabilization SystemParadigm Spine, LLC20093—
+4K090408Modification to: DSS Stabilization SystemParadigm Spine, LLC20094—
+4K071074Mykres Spinal SystemShowa Ika Kohgyo Co., Ltd.20080—
+4K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+4K061342Malibu Spinal SystemSeaspine, Inc.2006801
+4K051942Malibu Spinal SystemSeaspine, Inc.20058111
+4K051663Malibu Spinal SystemSeaspine, Inc.200581—
+4K043232Ucr Spinal SystemSeaspine2004971
+4K043001MX Polyaxial Pedicle ScrewScient'X200437—
+4K042964MX Monoaxial Pedicle ScrewScient'X200438—
+4K042953Modification to Protex Stabilization SystemGlobus Medical, Inc.20040—
+4K032739Ucr Spinal SystemSeaspine2003174—
+4K021623Ucr Spinal System, 5.5MM, 8.0MM Screws & InstrumentsIame, Inc.2002175—
+5K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+5K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+5K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+5K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+5K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+5K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+5K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+5K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+5K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+5K241258Ingenix Spinal SystemIngenium Spine20240—
+5K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+5K240392JAZZ Spinal SystemImplanet20241—
+5K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+5K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+5K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+5K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+5K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—