510(k) Report

Devices descending from K903810

889 later devices reach Ace Cannulated Self Tapping Cancellous Bone Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—
+1K140891Biomet Cannulated Screw SystemBiomet, Inc.2014165
+1K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc.2012117
+1K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited20118—
+1K060736Smith & Nephew 6.5MM and 8.0MM Cannulated ScrewsSmith & Nephew, Inc.20065311
+1K051296Sijf Cannulated Screw SystemDepuy Spine, Inc.2005836—
+1K051642FR.O.H. Calcaneus Repair SystemI.T.S. Implantat-Technologie-Systeme GmbH2005281
+1K043410Epiphysis ScrewI.T.S. Implantat-Technologie-Systeme GmbH200512—
+1K990019DRG Medium Screw SystemDolphin Medical Technologies, Inc.19990—
+1K973810DRG Large Screw SystemDolphin Medical Technologies, Inc.19980—
+1K960533K3 Bone Screw SystemKinetikos Medical, Inc.199661—
+1K960537K2 Bone Screw SystemKinetikos Medical, Inc.199641—
+2K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+2K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+2K243761A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics20250—
+2K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+2K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+2K212979CalcShift™ Displacement Calcaneal Osteotomy SystemNextremity Solutions, Inc.20220—
+2K213199Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw SystemStryker GmbH20222—
+2K213301InCore Subtalar SystemNextremity Solutions, Inc.20210—
+2K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+2K193214WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System…Biomet, Inc.20203—
+2K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+2K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+2K150889Suture Wires and Wire LoopsZimmer, Inc.20152—
+2K150626Rush Medullary PinsZimmer, Inc.20150—
+2K1431883.Omm Biomet Cannulated Screw SystemBiomet Manufacturing Corp201481
+2K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc.2014462
+2K124027Monster Screw SystemApogee Orthosolutions201341—
+2K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.201333—
+2K110472SI-Fix Sacroiliac Joint Fusion SystemMedtronic Sofamor Danek201292—
+2K120493Mini Cannulated Headed and Headless Screw SetInstratek, Inc.2012391
+2K112028SI-Lok Sacroiliac Joint Fixation SystemGlobus Medical, Inc.2011238—
+2K102907Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc.2010245—
+2K093676Omnitech Large, Trimed Compression ScrewTriMed, Inc.201013—
+2K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009487—
+2K082874Biodrive Cannulated Screw SystemBiomet Trauma2009168—
+2K080398SI Joint Fusion SystemSI-BONE, Inc.2008144—
+2K082949Orthopediatrics Bone ScrewsOrthoPediatrics Corp.200811—
+2K080649Pogo ScrewFxdevices200815—
+2K072818Peri-Loc Periartricular LCK Pit Sys-Prox Fem Plates/Screws.Calbe AccessSmith & Nephew, Inc.200793—
+2K063166I.T.S. Pelvic Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH200692
+2K060156Straight Plate with Angular Stability & Screw SystemI.T.S. Implantat-Technologie-Systeme GmbH2006272
+2K023365Leforte System Bone ScrewJeil Medical Corporation200320—
+2K972217Orthopedic Screw SystemFerguson Medical19970—
+3K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+3K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+3K252312Eleganz IM Threaded Nail System (IM Threaded Nail System)Dev420250—
+3K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+3K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+3K243943TriMed® Compression ScrewsTriMed, Inc.20252—
+3K243835TiLink-P SI Joint Fusion SystemSurGenTec, LLC20240—
+3K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+3K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+3K233017TM Plating SystemTyber Medical, LLC20231—
+3K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+3K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+3K230446TiLink-L SI Joint Fusion SystemSurGenTec, LLC20233—
+3K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+3K221342REDEMPTION Beaming SystemVilex, LLC20220—
+3K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+3K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+3K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+3K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.20218—
+3K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+3K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+3K203405EVOS Large Fragment Plating SystemSmith & Nephew, Inc.20213—
+3K200291CREED™ Cannulated ScrewsGlw Medical, Inc.20202—
+3K201918EVOS Large Fragment Plating SystemSmith & Nephew, Inc.202044
+3K200987LTJ Screws and WasherAzurmeds, Inc.20201—
+3K190580NADIA SI Fusion SystemIlion Medical, Inc.20203—
+3K201556Intraosseous Fixation SystemExtremity Medical, LLC20200—
+3K191748Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine201922—
+3K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+3K183104Mini Cannulated Headed and Headless Screw SetStryker GmbH20190—
+3K190586Monster® Screw SystemParagon 28, Inc.201921—
+3K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+3K182919SI-Restore® Sacroiliac Joint Fixation SystemBiofusion Medical20191—
+3K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+3K181640X-BOLT Hip Fracture Fixation SystemX-Bolt Orthopaedics20181—
+3K181881Outlet Sacroiliac Joint Fusion SystemSij Surgical20184—
+3K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—
+3K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc.201830—
+3K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+3K173201UNITY Sacroiliac Joint Fixation SystemHuvexel Co., Ltd.20183—
+3K172785Conquest FNSmith & Nephew20178—
+3K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+3K171651Excelsius GPSGlobus Medical, Inc.2017691
+3K171595M.U.S.T. Sacral Iliac Screw and Pelvic Trauma SystemMedacta International S.A.201735—
+3K162153Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation SystemAscension Orthopedics20171—
+3K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+3K170594I.B.S. osteosynthesis screwsIn2bones Sas20171—
+3K162121Siconus SI Joint Fixation SystemCamber Spine Technologies20171—
+3K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc.20160—
+3K161755Integrity-SI TM Fusion SystemCoorstek Medical20162—
+3K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Medtronic Sofamor Danek201679—
+3K160652iFUSE Implant SystemSI-BONE, Inc.201683—
+3K152686Conquest FNSmith & Nephew201612—
+3K152681iFuse Implant System (R)SI-BONE, Inc.201684—
+3K151848Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle SystemZimmer, Inc.20161—