510(k) Report

Devices descending from K021564

201 later devices reach Incompass Spinal Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122733V2F Anterior Fixation SystemZimmer Spine, Inc.201217—
+1K110655Mahe Perfect Spine- Pedicle Screw SystemMahe Medical GmbH20110—
+1K091717Any Plus Spinal Fixation SystemGS Medical Co., Ltd.2010130—
+1K072672Sequoia Spinal System, Model 3300 SeriesAbbott Spine, Inc.200702
+1K030087Spinal Concepts, Inc. Bacfix TI Spinal SystemSpinal Concepts, Inc.20030—
+1K030625Spinal Concepts Inc. PathfinderSpinal Concepts, Inc.20031096
+1K023644Modification to Incompass Spinal Fixation SystemSpinal Concepts, Inc.20021221
+2K243073AnyPlus Navigated Instruments SystemGS Medical Co., Ltd.20240—
+2K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+2K172546AnyPlus® Spinal Fixation SystemGS Medical Co., Ltd.201712—
+2K143110GALAXY MIS Screw SystemBm Korea20152—
+2K143626inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating…Zimmer Spine, Inc.201516—
+2K141695Acrosspine Pedicle Screw SystemArthro-Dif20140—
+2K133063Santis Pedicle Screw SystemLanterna Medical Technologies20142—
+2K131980Sequoia Pedicle Screw System Including Speedlink II Transverse Connector SystemZimmer Spine, Inc.201310—
+2K121568Dali Spinal Fixation SystemAccel Spine20121—
+2K122145Lanx Spinal Fixation SystemLanx, Inc.201271
+2K121130Polaris Spinal System-Ballista Spinal RodsBiomet Spine20121—
+2K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd.2012111—
+2K113044Synthes MirsSynthes Spine2011933
+2K100845Pathfinder II, Minimally Invasie Pedicle Screw System Model 3500 SeriesZimmer Spine, Inc.201045
+2K071174Pathfinder System Polyaxial Pedicle ScrewsAbbott Spine, Inc.2007944
+2K062670Vertiflex Spinal Screw SystemVertiflex (Tm), Incorporated200712—
+2K042640Uni-Thread Spinal SystemSpine Vision, Inc.20040—
+3K240592Wolff's Law Anterior Cervical Plate SystemSpinal Simplicity, LLC20240—
+3K240350AnyPlus II Spinal Fixation SystemGS Medical Co., Ltd.20240—
+3K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+3K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+3K223321Omnia Medical Coupler-C Anterior Cervical PlateOmnia Medical, LLC20230—
+3K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+3K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc.20233—
+3K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20224—
+3K201788EDEN Spinal Fixation SystemJmt Co., Ltd.20221—
+3K203507Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.20218—
+3K200790LnK Spinal Fixation System, OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.20205—
+3K192481AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.202013—
+3K192915GMA 2.0 Pedicle Screw SystemGrafton Medical Alliance20190—
+3K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.201910—
+3K173645JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd.20183—
+3K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+3K171838TiLock2 Spinal SystemGenesys Spine20174—
+3K152132X-spine Pedicle Screw SystemX-Spine Systems, Inc.201511
+3K142752Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System…Zimmer Spine, Inc.20150—
+3K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd.201533—
+3K150507Santis Pedicle Screw SystemLanterna Medical Technologies20150—
+3K132884Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20130—
+3K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+3K123451Polaris Spinal System - Ballista II RodsBiomet Spine (Aka Ebi, LLC)20120—
+3K120838Synthes Matrix SystemSynthes Spine201216—
+3K121671Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20120—
+3K120928Synthes Matrix SystemSynthes Spine20120—
+3K120571Synthes Uss ConnectorSynthes Spine201274—
+3K102870Exactech Proliant Polyaxial Pedicle Screw SystemExactech, Inc.20119—
+3K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc.20080—
+3K073245Extended Vertiflex Spinal Screw SystemVertiflex, Inc.200810—
+4K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+4K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+4K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+4K230116Vital™ Spinal Fixation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20235—
+4K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+4K230762EDEN Spinal Fixation MIS SystemJmt Co., Ltd.20230—
+4K220843OAKTREE Anterior Lumbar Plate and Screw SystemOak Tree Engineering, LLC20220—
+4K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+4K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+4K211932Fixxsure Anterior Lumbar Plate and Screw SystemOak Tree Engineering, LLC20211—
+4K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine202110—
+4K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+4K201427Trivergent Spinal Fixation SystemBenvenue Medical, Inc.20202—
+4K200794AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20208—
+4K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+4K190762The JASPER Spinal Fixation System IIGbs Commonwealth Co., Ltd.20191—
+4K182059Prase MIS Spinal SystemGbs Commonwealth Co., Ltd.20182—
+4K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+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—
+4K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemChoicespine, LP20170—
+4K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+4K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+4K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+4K153404Zavation Spinal SystemZavation, LLC20161—
+4K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+4K143230Palladian Lumbar Pedicle Screw SystemNeurostructures, Inc.20150—
+4K141282PGS 5.5 MM Cannulated Pedicle ScrewPinnacle Spine Group20141—
+4K141850Flospine Pedicle Screw SystemFlospine20140—
+4K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+4K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+4K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+4K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+5K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+5K253169Duet™ Spinal Fixation SystemBox Spine, LLC20261—
+5K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+5K240539Vital™ Spinal Fixation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20244—
+5K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+5K231840CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20230—
+5K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20231—