510(k) Report

Devices descending from K951725

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102235Mantis Spinal System & Mantis Redux Spinal SystemStryker Spine2010109—
+1K092631Mantis Redux Spinal SystemStryker Spine2009110—
+1K072116Savannah Lumbar Percutaneous Stabilization SystemNeurospine Innovations and Solutions200824—
+1K073151Mantis Spinal SystemStryker Corp.2007111—
+1K063428Xia Stainless Steel Spinal SystemStryker Spine2006204—
+1K062698Trio + Spinal SystemStryker Spine2006882
+1K061813Mantis Spinal SystemStryker Spine20061352
+1K052971Stryker Spine Trio Spinal Fixation SystemStryker Spine20051122
+1K043180Stryker Spine Trio PSStryker Spine200588—
+1K020293Osteonics Spinal SystemHowmedica Osteonics Corp.20020—
+1K013688Modification to Xia Spinal SystemHowmedica Osteonics Corp.2001205—
+1K993402Opus Spinal SystemHowmedica Osteonics Corp.19992—
+1K990158Osteonics Combination Screw Ring/BlockerOsteonics Corp.19991—
+1K990059Osteonics Spinal System-Expanded IndicationsHowmedica Osteonics Corp.19990—
+1K984302Osteonics Spinal System Cylindrical Bone ScrewsOsteonics Corp.19980—
+1K983152Osteonics Spinal System 5.5MM & 10.0MM Bone ScrewsOsteonics Corp.19980—
+2K153152Syzygy Stabilization SystemAmendia, Inc.201602
+2K132925Savannah-T, Reduction, Savannah-T, High-Top, Savannah-T, Monoaxial Mid-Top, Savannah-T…Amendia, Inc.2014231
+2K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+2K122845ES2 Spinal System Model 48280XXXXStryker Spine201228—
+2K120714Picasso Mis Spinal Fixation SystemAccel Spine20122—
+2K120434Power Adaptor Instrument AccessoryStryker Corp.201232—
+2K112643Focus Mis SystemL&K BIOMED Co., Ltd.201226—
+2K111478Stryker Spine Power Adaptor (Accessory Instrument)Stryker Corporation201134—
+2K103292Trio Trauma Spinal SystemStryker Corporation201185—
+2K100737Modification to: Trio+Spinal Fixation SystemStryker Spine201086—
+2K092605Xia 4.5 Spinal SystemStryker Spine200998—
+2K091291Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium RodStryker Spine2009169—
+2K070295Single Planar Multi Axial (Spma) Pedicle Screw SystemTrinity Orthopedics, LLC20070—
+2K070368Trio Plate System, Trio Spinal Fixation System, Trio+ Spinal SystemStryker Corp.200787—
+2K063601Pilot Spinal SystemLife Spine200724—
+2K052181Modification to Xia Spinal SystemStryker Spine2005202—
+2K030369Opus Spinal SystemHowmedica Osteonics Corp.20030—
+2K014229Modification to Opus Spinal SystemHowmedica Osteonics Corp.20021—
+3K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+3K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+3K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+3K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+3K200666Stryker Xia 3 Power AdaptorStryker Spine20203—
+3K192818Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal SystemStryker Corporation20208—
+3K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+3K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+3K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+3K172808CosmoLock Pedicle Screw SystemKalitec Direct, LLC20172—
+3K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+3K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+3K162367Erisma® LP MISClariance, Sas20162—
+3K161842Overwatch Spine SystemAmendia, Inc.201661
+3K152920Savannah-T® Pedicle Screw SystemAmendia, Inc.201601
+3K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+3K143110GALAXY MIS Screw SystemBm Korea20152—
+3K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd.201533—
+3K142381Xia 3 Spinal SystemStryker Corp.201483—
+3K140400ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20149—
+3K140219Picasso II Mis Spinal SystemAccel Spine20141—
+3K121568Dali Spinal Fixation SystemAccel Spine20121—
+3K111953Nautilus Spinal SystemLife Spine20123—
+3K121342Xia 4.5 Spinal SystemStryker Corp.201288—
+3K120928Synthes Matrix SystemSynthes Spine20120—
+3K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd.2012111—
+3K120140Focus Spinal SystemL&K BIOMED Co., Ltd.201225—
+3K111729Pilot Spinal SystemLife Spine, Inc.201113—
+3K110842Atlas Spine Pedicle Screw SystemAtlas Spine, Inc.20114—
+3K082617Trauson General Spinal System (GSS)Trauson (Jiangsu) Medical Instrument Co., Ltd.20098—
+3K070631Device Modification to Radius Spinal SystemStryker Spine2007201—
+4K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+4K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+4K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+4K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+4K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+4K233300POWEReam 1/4 DriveStryker Instruments20231—
+4K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+4K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+4K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+4K230974NIDO™ Pedicle Screw SystemKalitec Medical20230—
+4K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+4K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+4K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+4K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+4K230482Swedge™ Pedicle Screw Fixation SystemSpinal Resources, Inc.20231—
+4K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+4K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20224—
+4K201788EDEN Spinal Fixation SystemJmt Co., Ltd.20221—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+4K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+4K210549ARx Spinal SystemLife Spine, Inc.20211—
+4K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+4K200790LnK Spinal Fixation System, OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.20205—
+4K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+4K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+4K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+4K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+4K191810Curiteva Pedicle Screw SystemCuriteva, Inc.20190—
+4K172826Cellent Spinal SystemsJiangsu Trauhui Medical Instrument Co., Ltd.20180—
+4K173645JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd.20183—
+4K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+4K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—