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
+3K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+3K151718iFuse Implant SystemSI-BONE, Inc.201585—
+3K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+3K151407RECON systemNormed Medizin-Technik GmbH20154—
+3K151462SI-Technology® SI-Desis® ScrewsSi-Technology, LLC20155—
+3K150875iFuse Implant SystemSI-BONE, Inc.201586—
+3K151418Monster Screw SystemParagon 28201527—
+3K150714SI-BONE iFuse Implant SystemSI-BONE, Inc.201586—
+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—
+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—
+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—
+3K132876Arix Hand Locking SystemJeil Medical Corporation20130—
+3K131591Free Gliding Slipped Capital Femoral Epiphysis Screw (Scfe)Pega Medical, Inc.201302
+3K131405Ifuse Implant SystemSI-BONE, Inc.2013133—
+3K131311Arix Foot SystemJeil Medical Corporation20139—
+3K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+3K130008Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous…I.T.S. GmbH201311
+3K130479Ilizarov Drill Tip WiresSmith & Nephew, Inc.20136—
+3K123850Ifuse Implant SystemSI-BONE, Inc.2013134—
+3K123890Acumed Cannulated Screw SystemAcumed, LLC2013362
+3K123702Silex Sacroiliac Joint Fusion SystemX-Spine Systems, Inc.201349—
+3K122334Checkmate Small Bone Fusion SystemArthrosurface, Inc.20125—
+3K122538Acumed Pelvic Bone Plate SystemAcumed, LLC201241
+3K122074Ifuse Implant SystemSI-BONE, Inc.2012139—
+3K121148Samba Screw, 9MM Dia., 25MM Long, Sambia Screw, 9MM Dia., 30MM Long, Samba Screw 9MM…Medical Design, LLC201235—
+3K112794Eos Small Bone Fixation SystemTriMed, Inc.201294
+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
+3K093868I.T.S. LRS Locking Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH201011
+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
+3K080434Intertan CHS Locking Plate System Prox Fem Plates/ScrewSmith & Nephew, Inc.200835—
+3K050669Jeil Bone Fixation SystemJeil Medical Corporation20058—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K254280F.A.S.T ScrewSteps Ortho20260—
+4K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+4K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+4K262344Large Compression ScrewsTriMed, Inc.20260—
+4K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc.20260—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+4K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+4K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+4K261241TriMed Compression ScrewsTriMed, Inc.20260—
+4K260323OrthoPediatrics® Locking Cannulated Blade Plate SystemOrthoPediatrics Corp.20260—
+4K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+4K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical20260—
+4K253604TiLink-L Navigation InstrumentsSurGenTec, LLC20260—
+4K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+4K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+4K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+4K253611Falco Fusion SystemMcnicoll Surgical, Inc.20260—
+4K252322SIros-X SystemGenesys Spine20250—
+4K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+4K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+4K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+4K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+4K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+4K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+4K250247panaSIa SI Fusion SystemWenzel Spine, Inc.20250—
+4K241525ExcelsiusXR™Globus Medical, Inc.20250—
+4K251395The Rialto™ SI Fusion SystemMedtronic Sofamor Danek USA, Inc.20251—
+4K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+4K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+4K250403Catamaran SI Joint Fusion SystemTenon Medical20251—
+4K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+4K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+4K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+4K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+4K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+4K240160EGPS Navigated InstrumentsAstura Medical20240—
+4K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+4K240487EVOS Patella PlatesSmith & Nephew20240—
+4K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+4K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20241—
+4K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+4K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+4K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+4K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+4K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+4K232259Patriot-SI Posterior Implant SystemSpinal Simplicity, LLC20241—