510(k) Report

Devices descending from K051309

145 later devices reach Roi Fusion Rods & Plates through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+5K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+5K232878TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20230—
+5K231831TiLink-L Joint Fusion SystemSurgentec20232—
+5K231951SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20231—
+5K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+5K230689T-FIX™ 3DSI Joint Fusion SystemCutting Edge Spine, LLC20230—
+5K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc.20232—
+5K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+5K222774iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.202220—
+5K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+5K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+5K200696FIREBIRD SI Fusion SystemOrthofix, Inc.2020291
+5K190230iFuse Implant System®SI-BONE, Inc.201957—
+6K261381TiLink-L™ SI Joint Fusion SystemSurGenTec, LLC20260—
+6K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+6K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+6K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+6K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+6K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLC20251—
+6K250001Patriot SI Implant SystemSpinal Simplicity, LLC20250—
+6K242414TiLink-P Joint Fusion SystemSurGenTec, LLC20240—
+6K242141TiLink-P SI Joint Fusion SystemSurGenTec, LLC20241—
+6K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+6K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+6K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+6K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20231—
+6K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+6K201664FIREBIRD SI Fusion SystemOrthofix, Inc.202026—
+7K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+7K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+7K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+7K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+7K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+7K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+7K203138FIREBIRD SI Fusion SystemOrthofix, Inc.202025—
+8K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+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—
+8K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+8K210667FIREBIRD SI Fusion SystemOrthofix, Inc.202119—
+9K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+9K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+10K252088Firebird SI Navigation SystemOrthofix US, LLC20251—