510(k) Report

Devices descending from K000080

916 later devices reach Asnis Iii Cannulated Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K214123T-FIX® 3DSI Joint Fusion SystemCutting Edge Spine, LLC20221—
+3K220892ExsoMed INnate NanoTM Lag Screw SystemExsomed Corp.20220—
+3K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.20218—
+3K213214Xpert WristNewclip Technics20210—
+3K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+3K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.2021171
+3K203405EVOS Large Fragment Plating SystemSmith & Nephew, Inc.20213—
+3K203671M.U.S.T. Sacral Iliac Screw and Pelvic Trauma SystemMedacta International S.A.20212—
+3K200291CREED™ Cannulated ScrewsGlw Medical, Inc.20202—
+3K201918EVOS Large Fragment Plating SystemSmith & Nephew, Inc.202044
+3K202589APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS…Medartis AG202061
+3K200987LTJ Screws and WasherAzurmeds, Inc.20201—
+3K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+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—
+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—
+3K180932Diamond Orthopedic Bone Fixation Screws and PinsDiamond Orthopedic, LLC20180—
+3K173201UNITY Sacroiliac Joint Fixation SystemHuvexel Co., Ltd.20183—
+3K172785Conquest FNSmith & Nephew20178—
+3K172943Flex-Thread Fibula Pin SystemIntrafuse, LLC20174—
+3K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+3K171651Excelsius GPSGlobus Medical, Inc.2017691
+3K162153Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation SystemAscension Orthopedics20171—
+3K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+3K170687Flower Bone Screw SetFlower Orthopedics Corporation20170—
+3K170594I.B.S. osteosynthesis screwsIn2bones Sas20171—
+3K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+3K163487Ultima HA Coated Half Pins and WireVilex IN Tennessee, Inc.20174—
+3K162121Siconus SI Joint Fixation SystemCamber Spine Technologies20171—
+3K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc.20160—
+3K161755Integrity-SI TM Fusion SystemCoorstek Medical20162—
+3K161778ToeTac™ 10° Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20160—
+3K160791AmorChem Titanium Porous Fixation DeviceAmorchem Holdings, Inc.20160—
+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—
+3K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+3K151718iFuse Implant SystemSI-BONE, Inc.201585—
+3K151407RECON systemNormed Medizin-Technik GmbH20154—
+3K151462SI-Technology® SI-Desis® ScrewsSi-Technology, LLC20155—
+3K151146N-Force Fixation SystemInnovision, Inc.20151—
+3K150875iFuse Implant SystemSI-BONE, Inc.201586—
+3K151418Monster Screw SystemParagon 28201527—
+3K150889Suture Wires and Wire LoopsZimmer, Inc.20152—
+3K150443ToeTac Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20151—
+3K150626Rush Medullary PinsZimmer, Inc.20150—
+3K150714SI-BONE iFuse Implant SystemSI-BONE, Inc.201586—
+3K142776Flow-ScrewFlow-Fx, LLC20151—
+3K141246Life Spine Sacroiliac Joint Fixation SystemLife Spine, Inc.201529—
+3K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201579—
+3K141549SImmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc.201563—
+3K1431883.Omm Biomet Cannulated Screw SystemBiomet Manufacturing Corp201481
+3K143050VLP Mini-Mod Small Bone Plating System 1.5mm Plates and ScrewsSmith & Nephew, Inc.20148—
+3K141106Frontier Devices Fusio Screw Fuze SystemFolsom Metal Products, Inc. Dba Frontier Devices20143—
+3K140431Pediloc Fragment SystemOrthoPediatrics Corp.20141—
+3K141049Ifuse Implant SystemSI-BONE, Inc.201488—
+3K140891Biomet Cannulated Screw SystemBiomet, Inc.2014165
+3K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+3K140408Salvation Osteopenic ScrewWrightmedicaltechnologyinc20141—
+3K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.2014322
+3K140018TSP Hip Fracture Plating SystemBiomet, Inc.201412
+3K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+3K140079Silex Sacroiliac Joint Fusion SystemX-Spine Systems, Inc.201412—
+3K132244N-Force Fixation SystemInnovision, Inc.20143—
+3K133460Aptus Cannulated Compression ScrewsMedartis AG20138—
+3K131591Free Gliding Slipped Capital Femoral Epiphysis Screw (Scfe)Pega Medical, Inc.201302
+3K131405Ifuse Implant SystemSI-BONE, Inc.2013133—
+3K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+3K130479Ilizarov Drill Tip WiresSmith & Nephew, Inc.20136—
+3K123850Ifuse Implant SystemSI-BONE, Inc.2013134—
+3K123702Silex Sacroiliac Joint Fusion SystemX-Spine Systems, Inc.201349—
+3K122334Checkmate Small Bone Fusion SystemArthrosurface, Inc.20125—
+3K122074Ifuse Implant SystemSI-BONE, Inc.2012139—
+3K121148Samba Screw, 9MM Dia., 25MM Long, Sambia Screw, 9MM Dia., 30MM Long, Samba Screw 9MM…Medical Design, LLC201235—
+3K120360Ortho Solutions Trauma Plates for OsteosysnthesisOrtho Solutions Limited20122—
+3K112794Eos Small Bone Fixation SystemTriMed, Inc.201294
+3K121004Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co.20122—
+3K112406Peri-Loc Proximal Femur Locking Bone PlatesSmith & Nephew, Inc.20113—
+3K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc.2011161—
+3K110959Orthopediatrics Blade Plate SystemOrthoPediatrics Corp.201123
+3K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc.201169—
+3K111086Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp.201171
+3K110838Ifuse Implant SystemSI-BONE, Inc.2011143—
+3K110512Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc.2011241—
+3K093047Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc.2010511
+3K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010228—
+3K100325Peri-Loc Locking Hole Inserts and Cable AccessoriesSmith & Nephew, Inc.201038—
+3K093629Solitaire and Solitaire Peek Anterior Spinal SystemBiomet Spine20101431
+3K092189Pogo ScrewFxdevices20091—
+3K083032Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc.2009772