510(k) Report

Devices descending from K944330

172 later devices reach Acutrak Plus Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—
+5K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+5K203110iFuse Implant System - iFuse NavigationSI-BONE, Inc.20201—
+5K201538Life Spine SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.202013—
+5K190580NADIA SI Fusion SystemIlion Medical, Inc.20203—
+5K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+5K183342SambaScrew 3D SI Fusion SystemOrthofix, Inc.201931—
+5K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+5K182983iFuse Implant System®SI-BONE, Inc.201871—
+5K152237The Entasis Dual-Lead Sacroiliac ImplantCorelink, LLC201611—
+6K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+6K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+6K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+6K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+6K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+6K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+6K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+6K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20250—
+6K241895Cannulated PsiFGuardSpineguard20240—
+6K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+6K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+6K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+6K232149BowTie™ SI Joint Fusion SystemSail Fusion, LLC20242—
+6K232259Patriot-SI Posterior Implant SystemSpinal Simplicity, LLC20241—
+6K240720TiLink-P SI Joint Fusion SystemSurGenTec, LLC20243—
+6K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+6K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+6K232878TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20230—
+6K231831TiLink-L Joint Fusion SystemSurgentec20232—
+6K231951SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20231—
+6K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+6K230689T-FIX™ 3DSI Joint Fusion SystemCutting Edge Spine, LLC20230—
+6K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc.20232—
+6K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+6K222774iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.202220—
+6K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+6K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+6K200696FIREBIRD SI Fusion SystemOrthofix, Inc.2020291
+6K190230iFuse Implant System®SI-BONE, Inc.201957—
+7K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+7K261381TiLink-L™ SI Joint Fusion SystemSurGenTec, LLC20260—
+7K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+7K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+7K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+7K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+7K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLC20251—
+7K250001Patriot SI Implant SystemSpinal Simplicity, LLC20250—
+7K242414TiLink-P Joint Fusion SystemSurGenTec, LLC20240—
+7K242141TiLink-P SI Joint Fusion SystemSurGenTec, LLC20241—
+7K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+7K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+7K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+7K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20231—
+7K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+7K201664FIREBIRD SI Fusion SystemOrthofix, Inc.202026—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+8K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+8K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+8K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+8K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+8K203138FIREBIRD SI Fusion SystemOrthofix, Inc.202025—
+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—
+9K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+9K210667FIREBIRD SI Fusion SystemOrthofix, Inc.202119—
+10K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+10K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+11K252088Firebird SI Navigation SystemOrthofix US, LLC20251—