510(k) Report

Devices descending from K992147

451 later devices reach Triple-Fix Spinal Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K143110GALAXY MIS Screw SystemBm Korea20152—
+4K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd.201533—
+4K143417ANAX 5.5 Spinal SystemU&I Corporation20154—
+4K143149Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201584—
+4K141695Acrosspine Pedicle Screw SystemArthro-Dif20140—
+4K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+4K140010Fortress Pedicle Screw SystemSpineology, Inc.201411—
+4K140219Picasso II Mis Spinal SystemAccel Spine20141—
+4K133221Arsenal Spinal Fixation SystemAlphatec Spine, Inc.20141502
+4K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+4K133063Santis Pedicle Screw SystemLanterna Medical Technologies20142—
+4K132101Anax 5.5 Spinal SystemU&I Corporation201313—
+4K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+4K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+4K132365Spondylolisthesis Spinal Fixation, Spinal Pedicle FixationAccel Spine201322
+4K131522Core Pedicle Screw SystemCore-Nexus20130—
+4K122145Lanx Spinal Fixation SystemLanx, Inc.201271
+4K113058Tiger Spine SystemCorelink, LLC201281—
+4K120538Palls M Spinal SystemKorea Bone Bank Co., Ltd.20121—
+4K111634Xenon (TM) Pedicle Screw SystemAlphatec Spine, Inc.20120—
+4K111362Rexious Spinal Fixation SystemDio Medical Co., Ltd.201111—
+4K093692Quantum/ Streamline Spinal System Model 02-Series and 10-SeriesPioneer Surgical Technology201090—
+4K093771Quantum/Streamline TL Mis Spinal SystemPioneer Surgical Technology20108—
+4K100373Tyche Pedicle Screw SystemKyung Won Medical Co., Ltd.20104—
+4K090424DVX Spine SystemBk Meditech, Co., Ltd.20090—
+4K080518Pioneer Surgical Technology Quantum Spinal SystemPioneer Surgical Technology2008174—
+4K080026Quantum-Mis Cannulated SystemPioneer Surgical Technology200812—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+5K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+5K241657MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti.20243—
+5K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+5K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+5K240737G Surgical Marksman MIS SystemG Surgical, LLC20240—
+5K233960INNOVERSE Spinal SystemInnosys Co., Ltd.20240—
+5K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+5K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+5K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+5K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+5K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+5K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+5K201788EDEN Spinal Fixation SystemJmt Co., Ltd.20221—
+5K220285PINE Pedicle Screw SystemTdm Co., Ltd.20220—
+5K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+5K210420Goblin and Goblin LS Pedicle Screw SystemsMedynus, Inc.20211—
+5K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+5K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+5K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+5K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+5K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+5K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+5K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+5K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+5K193219G Surgical Marksman SystemG Surgical, LLC20191—
+5K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+5K192915GMA 2.0 Pedicle Screw SystemGrafton Medical Alliance20190—
+5K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+5K190762The JASPER Spinal Fixation System IIGbs Commonwealth Co., Ltd.20191—
+5K181824CBT Screw Fixation SystemU&I Corporation20180—
+5K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+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—
+5K180433Ennovate®Aesculap Implant Systems, LLC201811
+5K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+5K180324Patriot Spinal Fixation SystemValorus Spine20180—
+5K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+5K180156SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation SystemGlobus Medical, Inc.20185—
+5K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+5K173524ANAX 5.5™ Spinal SystemU&I Corporation201721
+5K173131Rexious Spinal Fixation SystemHuvexel Co., Ltd.20175—
+5K171838TiLock2 Spinal SystemGenesys Spine20174—
+5K171813OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd.201730—
+5K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+5K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+5K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd.20166—
+5K162189ANAX™ 5.5 Spinal SystemU&I Corporation20163—
+5K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+5K151977icotec Pedicle SystemIcotec AG201630—
+5K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+5K151974Polaris Spinal SystemBiomet Spine201516—
+5K152132X-spine Pedicle Screw SystemX-Spine Systems, Inc.201511
+5K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—
+5K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+5K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+5K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+5K150507Santis Pedicle Screw SystemLanterna Medical Technologies20150—
+5K140359Maximis Spinal Fixation SystemValorem Surgical20150144
+5K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+5K142737MAS PLIF Fixation systemNu Vasive, Incorporated20141—
+5K143403Threshold Pedicular Fixation SystemSpineology, Inc.20148—
+5K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+5K142499Reline SystemNu Vasive, Incorporated201478—
+5K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+5K131250Tiger Spine SystemCorelink, LLC201340—
+5K131785Pagoda Pedicle Screw SystemOrtho Development Corp.20136—
+5K130286Streamline Mis Spinal Fixation SystemPioneer Surgical Technology, Inc.201371