510(k) Report

Devices descending from K951725

264 later devices reach Osteonics Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation20179—
+4K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+4K171807ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20177—
+4K171813OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd.201730—
+4K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151
+4K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+4K151458Double Medical Universal Spine SystemDouble Medical Technology, Inc.20160—
+4K161766PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.201618—
+4K150684WASTON General Spinal SystemChangzhou Waston Medical Appliance Co., Ltd.20150—
+4K151216Everest Spinal SystemK2m, Inc.201511—
+4K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+4K142438Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.)20154—
+4K134011General Spinal SystemChangzhou Dean Medical Instrument Co, Ltd.20140—
+4K140229General Spinal SystemTianjin Walkman Biomaterial Co., Ltd.20140—
+4K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+4K111634Xenon (TM) Pedicle Screw SystemAlphatec Spine, Inc.20120—
+4K111690Devine Spinal SystemChangzhou Orthmed Medical Instrument Co., Ltd.20113—
+4K112759Apclo Pedicle Screw SystemsAtlas Spine, Inc.20112—
+4K101144Modification to:Radius Spinal SystemStryker Spine201090—
+4K082608Radius Spinal System, Vitallium Rod #486613601Stryker Spine2008200—
+5K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+5K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+5K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+5K252461Swedge™ Pedicle Screw Fixation System Bezier RodSpinal Resources, Inc.20260—
+5K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+5K253249TriALTIS™ Spine SystemMedos International SARL20251—
+5K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+5K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+5K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K240526POWEReam Xia/SerratoStryker Instruments20240—
+5K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+5K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K230762EDEN Spinal Fixation MIS SystemJmt Co., Ltd.20230—
+5K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+5K223294SpineJack® Expansion KitStryker Instruments20221—
+5K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+5K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+5K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+5K220025ARx® Spinal SystemLife Spine, Inc.20220—
+5K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+5K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+5K200070ARx Spinal SystemLife Spine, Inc.20209—
+5K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+5K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+5K191575ARx Spinal SystemLife Spine, Inc.201910—
+5K190163ALARA Neuro Access KitSurGenTec, LLC20192—
+5K190762The JASPER Spinal Fixation System IIGbs Commonwealth Co., Ltd.20191—
+5K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.201910—
+5K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+5K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20193—
+5K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+5K183168OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.201823—
+5K183117PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.20184—
+5K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+5K182240PASS LP Spinal SystemMedicrea International SA20182—
+5K182059Prase MIS Spinal SystemGbs Commonwealth Co., Ltd.20182—
+5K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+5K172267IRENE Thoracolumbar Fixation SystemTianjin Zhengtian Medical Instrument Co., Ltd.20180—
+5K173508Everest Spinal SystemK2m20189—
+5K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+5K161151Spinal fixation systemCanwell Medical Co., Ltd.20161—
+5K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+5K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+5K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+5K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+5K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+5K0910675.5 Polaris Spinal SystemBiomet Spine200979—
+6K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.20260—
+6K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+6K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+6K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+6K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+6K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+6K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K250637VCFix Spinal SystemAmber Implants20250—
+6K243945ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20250—
+6K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+6K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20241—
+6K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+6K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+6K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+6K231479TriALTIS Spine SystemMedos International SARL20238—
+6K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+6K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+6K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+6K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+6K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+6K200794AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20208—
+6K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20192—
+6K190376PASS LP Spinal SystemMedicrea International SA201915
+6K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+6K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+6K180433Ennovate®Aesculap Implant Systems, LLC201811
+6K180376K2M Patient Specific RodsK2m, Inc.20182—