510(k) Report

Devices descending from K092825

178 later devices reach Apex Spine System 5.50 MM Titanium Rod & Polyaxial Screw Washer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+1K150417Astra Spine SystemSpinecraft, LLC201521—
+1K132603Apex Spine SystemSpinecraft, LLC201325—
+1K121568Dali Spinal Fixation SystemAccel Spine20121—
+1K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd.2012111—
+1K110906Apex Spine SystemSpinecraft, LLC2011103—
+1K102488Apex Spine System W/ Cocr RodsSpinecraft, LLC2010177—
+2K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+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—
+2K223273ASTRA Spine SystemSpinecraft, LLC20228—
+2K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+2K211323ASTRA Spine SystemSpinecraft, LLC202112—
+2K200790LnK Spinal Fixation System, OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.20205—
+2K173645JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd.20183—
+2K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+2K162786PASS LP Spinal SystemMedicrea International SA20176—
+2K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd.201533—
+2K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+2K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+2K113058Tiger Spine SystemCorelink, LLC201281—
+3K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+3K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+3K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+3K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+3K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+3K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+3K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+3K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+3K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+3K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+3K190762The JASPER Spinal Fixation System IIGbs Commonwealth Co., Ltd.20191—
+3K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+3K182240PASS LP Spinal SystemMedicrea International SA20182—
+3K182059Prase MIS Spinal SystemGbs Commonwealth Co., Ltd.20182—
+3K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+3K171813OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd.201730—
+3K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+3K151977icotec Pedicle SystemIcotec AG201630—
+3K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+3K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+3K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+3K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+3K131250Tiger Spine SystemCorelink, LLC201340—
+3K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+3K131785Pagoda Pedicle Screw SystemOrtho Development Corp.20136—
+3K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+4K252322SIros-X SystemGenesys Spine20250—
+4K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+4K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+4K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+4K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+4K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+4K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+4K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+4K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+4K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+4K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+4K222789VADER® Pedicle System, G21 CementIcotec AG202352
+4K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+4K203023Pisces Spinal SystemOrtho Development Corporation20210—
+4K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+4K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+4K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+4K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.201910—
+4K190376PASS LP Spinal SystemMedicrea International SA201915
+4K183168OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.201823—
+4K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+4K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+4K180433Ennovate®Aesculap Implant Systems, LLC201811
+4K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+4K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+4K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+4K151974Polaris Spinal SystemBiomet Spine201516—
+4K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+4K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+4K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+4K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+4K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+4K133369Tiger Spine SystemCorelink, LLC201429—
+5K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+5K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+5K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+5K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+5K232628VADER® Pedicle SystemIcotec AG20241—
+5K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+5K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+5K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+5K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+5K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+5K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+5K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—