510(k) Report

Devices descending from K043522

46 later devices reach Issys Pedicle Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113361Securis Spinal FixationCumtom Spine20120—
+1K072866Issys LP Spinal Fixation SystemCustom Spine, Inc.200721
+1K070245Capsure Pedicle Screw SystemSpine Wave, Inc.200742—
+2K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+2K120646Capsure (R) PS SystemSpine Wave, Inc.20120—
+2K111099Issys LP Spinal Fixation SystemCustom Spine, Inc.201111
+2K081228Capsure PS (R) Spine SystemSpine Wave, Inc.200839—
+3K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+3K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+3K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+3K111913Capsure (R) PS SystemSpine Wave, Inc.20111—
+3K100605Mis SystemSpine Wave, Inc.201033—
+3K083353Capsure (R) PS SystemSpine Wave, Inc.200836—
+4K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc.20170—
+4K151813Sniper Spine SystemSpine Wave, Inc.20159—
+4K123164Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.201336
+4K111115Captiva Spine Caplox II Spinal Fixation SystemCaptiva Spine, Inc.201116—
+4K100122Modification to Capsure PS SystemSpine Wave, Inc.20102—
+4K083743Capsure PS SystemSpine Wave, Inc.20093—
+5K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+5K152174Sniper Spine SystemSpine Wave, Inc.20158—
+5K143377PedFuse Pedicle Screw SystemSpinefrontier, Inc.20150—
+5K133153Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.20141—
+5K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+5K120292Caplox II Pedicle Screw SystemCaptiva Spine, Inc.2012151
+6K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+6K160003Sniper (R) Spine SystemSpine Wave, Inc.20167—
+6K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20165—
+6K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+7K240392JAZZ Spinal SystemImplanet20241—
+7K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+7K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+7K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+7K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+7K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+7K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+7K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+7K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+8K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+8K252437JAZZ Spinal SystemImplanet20250—
+8K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+8K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+8K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+9K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+9K182470Plateau Spacer SystemLife Spine20180—
+10K222362Salvo® Spine SystemSpine Wave, Inc.20223—