510(k) Report

Devices descending from K131405

133 later devices reach Ifuse Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20231—
+4K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+4K213667iFuse-TORQ® Implant SystemSI-BONE, Inc.202215—
+4K200696FIREBIRD SI Fusion SystemOrthofix, Inc.2020291
+4K190230iFuse Implant System®SI-BONE, Inc.201957—
+5K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+5K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+5K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+5K243835TiLink-P SI Joint Fusion SystemSurGenTec, LLC20240—
+5K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+5K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+5K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+5K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+5K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+5K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+5K201664FIREBIRD SI Fusion SystemOrthofix, Inc.202026—
+5K193524SI-BONE iFuse Implant System®SI-BONE, Inc.202054—
+6K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K251365OptumSI Implant SystemSi Solutions, LLC20250—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+6K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+6K230817TORPEDO Implant System®Deltacor GmbH20240—
+6K222512Integrity-SI Fusion SystemOsteoCentric Technologies20221—
+6K203138FIREBIRD SI Fusion SystemOrthofix, Inc.202025—
+6K201538Life Spine SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.202013—
+7K214123T-FIX® 3DSI Joint Fusion SystemCutting Edge Spine, LLC20221—
+7K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+7K210667FIREBIRD SI Fusion SystemOrthofix, Inc.202119—
+8K230689T-FIX™ 3DSI Joint Fusion SystemCutting Edge Spine, LLC20230—
+8K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+8K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+9K252088Firebird SI Navigation SystemOrthofix US, LLC20251—