510(k) Report

Devices descending from K053573

181 later devices reach GSS Pedicle Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.201910—
+1K172546AnyPlus® Spinal Fixation SystemGS Medical Co., Ltd.201712—
+1K102574Palla M Spinal SystemKorea Bone Bank Co., Ltd.20112—
+1K100765Fixpine II SystemDio Medical Co., Ltd.201023—
+1K092076Aegis & Aegis II Spinal SystemCorentec Co., Ltd.20103—
+1K091717Any Plus Spinal Fixation SystemGS Medical Co., Ltd.2010130—
+1K082509Eos Spinal SystemKorea Bone Bank Co., Ltd.2008140—
+1K081108Monopoly Pedicle Screw SystemSignus Medical, LLC20080—
+2K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+2K243073AnyPlus Navigated Instruments SystemGS Medical Co., Ltd.20240—
+2K240350AnyPlus II Spinal Fixation SystemGS Medical Co., Ltd.20240—
+2K231737ANAX™ 5.5 Spinal SystemInnosys Co., Ltd.20231—
+2K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+2K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+2K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+2K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20224—
+2K222415Rexious Spinal Fixation SystemDio Medical Corporation20221—
+2K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+2K200794AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20208—
+2K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+2K143110GALAXY MIS Screw SystemBm Korea20152—
+2K143417ANAX 5.5 Spinal SystemU&I Corporation20154—
+2K141695Acrosspine Pedicle Screw SystemArthro-Dif20140—
+2K140010Fortress Pedicle Screw SystemSpineology, Inc.201411—
+2K133063Santis Pedicle Screw SystemLanterna Medical Technologies20142—
+2K132101Anax 5.5 Spinal SystemU&I Corporation201313—
+2K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+2K132365Spondylolisthesis Spinal Fixation, Spinal Pedicle FixationAccel Spine201322
+2K131522Core Pedicle Screw SystemCore-Nexus20130—
+2K121568Dali Spinal Fixation SystemAccel Spine20121—
+2K122145Lanx Spinal Fixation SystemLanx, Inc.201271
+2K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd.2012111—
+2K120538Palls M Spinal SystemKorea Bone Bank Co., Ltd.20121—
+2K111362Rexious Spinal Fixation SystemDio Medical Co., Ltd.201111—
+2K103085Venus Basic Spinal Fixation SystemL&K BIOMED Co., Ltd.2011123—
+2K100706Venus Basic Spinal Fixation SystemL&K BIOMED Co., Ltd.2010124—
+3K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+3K233960INNOVERSE Spinal SystemInnosys Co., Ltd.20240—
+3K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+3K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+3K201788EDEN Spinal Fixation SystemJmt Co., Ltd.20221—
+3K220285PINE Pedicle Screw SystemTdm Co., Ltd.20220—
+3K210420Goblin and Goblin LS Pedicle Screw SystemsMedynus, Inc.20211—
+3K200790LnK Spinal Fixation System, OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.20205—
+3K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+3K192915GMA 2.0 Pedicle Screw SystemGrafton Medical Alliance20190—
+3K181824CBT Screw Fixation SystemU&I Corporation20180—
+3K173645JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd.20183—
+3K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+3K173524ANAX 5.5™ Spinal SystemU&I Corporation201721
+3K173131Rexious Spinal Fixation SystemHuvexel Co., Ltd.20175—
+3K171838TiLock2 Spinal SystemGenesys Spine20174—
+3K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+3K162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd.20164—
+3K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd.20166—
+3K162189ANAX™ 5.5 Spinal SystemU&I Corporation20163—
+3K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+3K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+3K152132X-spine Pedicle Screw SystemX-Spine Systems, Inc.201511
+3K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—
+3K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd.201533—
+3K150507Santis Pedicle Screw SystemLanterna Medical Technologies20150—
+3K140359Maximis Spinal Fixation SystemValorem Surgical20150144
+3K143403Threshold Pedicular Fixation SystemSpineology, Inc.20148—
+3K140219Picasso II Mis Spinal SystemAccel Spine20141—
+3K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+3K120714Picasso Mis Spinal Fixation SystemAccel Spine20122—
+3K120140Focus Spinal SystemL&K BIOMED Co., Ltd.201225—
+3K112643Focus Mis SystemL&K BIOMED Co., Ltd.201226—
+4K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS…MANTIZ Co., Ltd.20260—
+4K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+4K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+4K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+4K230762EDEN Spinal Fixation MIS SystemJmt Co., Ltd.20230—
+4K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+4K201427Trivergent Spinal Fixation SystemBenvenue Medical, Inc.20202—
+4K190762The JASPER Spinal Fixation System IIGbs Commonwealth Co., Ltd.20191—
+4K182059Prase MIS Spinal SystemGbs Commonwealth Co., Ltd.20182—
+4K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+4K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+4K172469TiLock Modular Spinal SystemGenesys Spine20170—
+4K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+4K171813OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd.201730—
+4K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+4K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+4K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+4K161766PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.201618—
+4K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+4K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+4K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+4K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+5K253169Duet™ Spinal Fixation SystemBox Spine, LLC20261—
+5K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+5K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+5K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+5K183168OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.201823—
+5K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+5K183117PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.20184—
+5K180433Ennovate®Aesculap Implant Systems, LLC201811