510(k) Report

Devices descending from K992276

171 later devices reach Modification to Silhouette Spinal Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+6K220025ARx® Spinal SystemLife Spine, Inc.20220—
+6K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+6K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+6K210549ARx Spinal SystemLife Spine, Inc.20211—
+6K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+6K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+6K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+6K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+6K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+6K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+6K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc.20170—
+6K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20167—
+6K151813Sniper Spine SystemSpine Wave, Inc.20159—
+6K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+6K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+6K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+6K123164Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.201336
+6K111115Captiva Spine Caplox II Spinal Fixation SystemCaptiva Spine, Inc.201116—
+6K100122Modification to Capsure PS SystemSpine Wave, Inc.20102—
+6K083743Capsure PS SystemSpine Wave, Inc.20093—
+7K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+7K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+7K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+7K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+7K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+7K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+7K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+7K220888MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A.20221—
+7K200070ARx Spinal SystemLife Spine, Inc.20209—
+7K191575ARx Spinal SystemLife Spine, Inc.201910—
+7K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+7K181883FIREFLY® Midline Navigation GuideMighty Oak Medical, Inc.20184—
+7K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20185—
+7K152174Sniper Spine SystemSpine Wave, Inc.20158—
+7K143377PedFuse Pedicle Screw SystemSpinefrontier, Inc.20150—
+7K133153Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.20141—
+7K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+7K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+7K120292Caplox II Pedicle Screw SystemCaptiva Spine, Inc.2012151
+8K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K253472FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical20260—
+8K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+8K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+8K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+8K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+8K160003Sniper (R) Spine SystemSpine Wave, Inc.20167—
+8K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20165—
+8K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+8K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+9K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+9K240392JAZZ Spinal SystemImplanet20241—
+9K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+9K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+9K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+9K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+9K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+9K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+9K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+9K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+10K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+10K252437JAZZ Spinal SystemImplanet20250—
+10K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+10K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+10K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+11K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+11K182470Plateau Spacer SystemLife Spine20180—
+12K222362Salvo® Spine SystemSpine Wave, Inc.20223—