510(k) Report

Devices descending from K112028

238 later devices reach SI-Lok Sacroiliac Joint Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+5K231840CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20230—
+5K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+5K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+5K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc.20233—
+5K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc.20226—
+5K220195iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc.202232—
+5K203138FIREBIRD SI Fusion SystemOrthofix, Inc.202025—
+5K203110iFuse Implant System - iFuse NavigationSI-BONE, Inc.20201—
+5K190230iFuse Implant System®SI-BONE, Inc.201957—
+6K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+6K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+6K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+6K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+6K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K232318VICTORY™ Lumbar Plate SystemGlobus Medical, Inc.20230—
+6K222774iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.202220—
+6K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+6K210667FIREBIRD SI Fusion SystemOrthofix, Inc.202119—
+6K193524SI-BONE iFuse Implant System®SI-BONE, Inc.202054—
+7K251365OptumSI Implant SystemSi Solutions, LLC20250—
+7K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+7K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+7K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+7K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+7K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+8K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+8K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+9K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+9K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+9K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+9K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—