510(k) Report

Devices descending from K853033

696 later devices reach Hartshill Rect & Wires, Spinal Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K991662Titanium Hartshill SystemSurgicraft, Ltd.19990—
+1K965221Ransford Cervical Fixation SystemSurgicraft, Ltd.1997694—
+2K002733Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed2000671—
+2K982322Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa)1998692—
+2K983282Omi Occipital Cervical Loop, Model A1089Ohio Medical Instrument Co., Inc.19980—
+3K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+3K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+3K121979Pass Oct Spinal SystemMedicrea International201314—
+3K120467Spinal Elements Posterior Cervical/Thoracic Spinal SystemSpinal Elements, Inc.20121—
+3K101084Caspian Spinal SystemK2m, Inc.201062—
+3K092295Pioneer Posterior Cervico-Thoracic SystemPioneer Surgical Technology201024—
+3K080828Mountaineer Oct Spinal SystemDepuy Spine, Inc.2008242—
+3K070638Theken Atoll Cervico-Thoracic SystemTheken Spine, LLC200759—
+3K062934SierraSeaspine, Inc.200621—
+3K053418Synthes OC Fusion SystemSynthes Spine Co.Lp200625—
+3K052201Solanas Posterior Stabilization SystemAlphatec Spine, Inc.2005363
+3K052402Vertex Reconstruction SystemMedtronic Sofamor Danek2005180—
+3K050391Protex CT Cervicothoracic Spinal SystemGlobus Medical, Inc.2005148—
+3K042508Sumit Oct Spinal System and Mountaineer Oct Spinal SystemDepuy Spine, Inc.2004301—
+3K041203Summit Oct Spinal SystemDepuy Spine, Inc.2004657—
+3K030197Blackstone Posterior Cervical SystemBlackstone Medical, Inc.20031931
+3K030103Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed2003658—
+3K022190Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed2002659—
+3K013222Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed2001660—
+4K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+4K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+4K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+4K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+4K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+4K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+4K193129Yukon OCT Spinal SystemK2m, Inc.202001
+4K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+4K182182YUKON OCT Spinal SystemK2m20185—
+4K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+4K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+4K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+4K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20188—
+4K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+4K152211PCT SystemCentinel Spine, Inc.20150—
+4K150918PASS OCT Spinal SystemMedicrea International SA201513—
+4K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+4K142558Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m20140—
+4K141284Caspian Spinal SystemK2m, Inc.20140—
+4K133288Caspian Oct Spinal SystemK2m, Inc.201418—
+4K133214Blackbird Spinal SystemChoicespine, LP20143—
+4K131833Centurion Poct SystemOrthofix, Inc.20142—
+4K133698Synapse SystemSynthes USA Products, LLC20146—
+4K131427LOTUSSpinal Elements, Inc.20130—
+4K132332Mountaineer Oct Spinal SystemMedos International SARL20134—
+4K131119Solanas Posterior Stabilization SystemAlphatec Spine, Inc.201301
+4K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+4K121877Gibralt Occipital Plate Screws, Set Screw, Gibralt Occipital System Articulating Rod…Exactech, Inc.20134—
+4K121725Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc.201217—
+4K122163Certex Spinal Implant SystemX-Spine Systems, Inc.20122—
+4K122292Reliance Posterior Cervical- Thoracic SystemReliance Medical Systems, LLC20124—
+4K122378Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)201271
+4K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012102—
+4K112757Pioneer Posterior Cervico Thoracic SystemPioneer Surgical Technology, Inc.2012181
+4K113654CaspianK2m, Inc.201244—
+4K112025Sure Lok Mini Posterior Cervical/Upper Thoracic SystemSpinal USA20114—
+4K111183Ascent Posterior Occipital Thoracic (Poct) System (Titanium & Cobalt Chrome Rods)Orthofix, Inc.201122—
+4K110963Ellipse Occipito-Cervico-Thoracic Spinal SystemGlobus Medical, Inc.201198—
+4K110353Mountaineer Oct Spinal SystemDepuy Spine, Inc.2011156—
+4K103232Caspian Spinal SystemK2m, Inc.201146—
+4K103100Mountaineer Oct Spinal SystemDepuy Spine, Inc.2010184—
+4K093319Nuvasive Vuepoint Oct SystemNuvasive, Inc.201010—
+4K100191Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, Inc.20103—
+4K092656Lanx Posterior Cervicothoracic Spinal Fixation SystemLanx, Inc.20095—
+4K091359Gso PCT Spinal SystemGold Standard Orthopaedics, LLC20090—
+4K090565Ellipse Occipito-Cerico-Thoracic Spinal SystemGlobus Medical, Inc.2009101—
+4K083863Theken Atoll Oct Spinal SystemTheken Spine, LLC200921—
+4K083073Theken Atoll Cervico-Thoracic SystemTheken Spine, LLC20098—
+4K081906Protex CT Cervicothoracic Spinal SystemGlobus Medical, Inc.2008104—
+4K080790Modification to Theken Atoll Cervico-Thoracic SystemTheken Spine, LLC20089—
+4K072729SierraSeaspine, Inc.20085—
+4K080526Sierra SystemSeaspine, Inc.20089—
+4K080394Blackstone Ascent Posterior Occipital Cervico-Thoracic (Poct) SystemBlackstone Medical, Inc.2008124—
+4K073420Blackstone Ascent Multiaxial ScrewsBlackstone Medical, Inc.20089—
+4K073654Blackstone Ascent Poct System Parallel Rod ConnectorBlackstone Medical, Inc.2008129—
+4K072434Synthes OC Fusion and Synapse SystemsSynthes Spine Co.Lp20082—
+4K071905Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, LLC20076—
+4K071942Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek200724—
+4K072568Modification to Oasys SystemStryker Spine200744—
+4K070742Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek2007150—
+4K071380Modification to Solanas Posterior Stabilization SystemAlphatec Spine, Inc.2007183
+4K062879Traverse Oct Spinal Fixation SystemMedtronic Sofamor Danek, Inc.2006151—
+4K062174Modification to Expedium Spine SystemDepuy Spine, Inc.2006490—
+4K052734Modification to: Vertex Reconstruction SystemMedtronic Sofamor Danek2005175—
+4K050979S4 Spinal SystemAesculap, Inc.200567—
+4K042100Blackstone Ascent Poct System 5.5MM/3.0MM Single Axial ConnectorBlackstone Medical, Inc.2004139—
+4K033980Blackstone Ascent Poct System Hooks (System Modification)Blackstone Medical, Inc.2004134—
+5K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+5K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+5K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+5K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+5K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+5K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+5K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+5K231654NorthStar OCT SystemSeaspine, Inc.20230—
+5K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—