510(k) Report

Devices descending from K882831

77 later devices reach Ace Cancellous Bone Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072832Anterolateral and Medial Locking Plating SystemDePuy Orthopaedics, Inc.2007582
+1K072083Small Fragment Locking Plating SystemDePuy Orthopaedics, Inc.2007372
+2K243761A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics20250—
+2K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc.2012117
+2K110086Ifs Profile Plates, Screws, and WashersInternal Fixation Systems, Inc.20115—
+2K101421Medical Plates, Lateral Plates, Posterior Lateral Plates, Olecranon Plates Model…DePuy Orthopaedics, Inc.201032—
+2K092812Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia PlatesSynthes (Usa)201055—
+3K242988Genostis Osteosynthesis SystemGenostis AF20250—
+3K250055BPS - Bone Fragment Fixation Plates, Screws and WashersOrthonovis, Inc.20251—
+3K232394Internal Locking Plate and Screw Fixation SystemChangzhou Geasure Medical Apparatus and Instruments Co., Ltd.20230—
+3K193633APTUS® Ankle Trauma System 2.8/3.5Medartis AG202011—
+3K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand…Nebula Surgical Private Limited20193—
+3K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+3K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173—
+3K161747LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ®…Aap Implantate AG20160—
+3K153716GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.Gpc Medical, Ltd.201615—
+3K143721PRCT2Fx Solutions20150—
+3K141680AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN…Auxein Medical20151—
+3K143697Biomet Proximal Humerus Plating SystemBiomet Manufacturing20151718
+3K140216Orthopedic Fixation SystemsImpact Medical, LLC20140—
+3K133675Aap Loqteq Distal Anterolateral Tibia Plate 3.5Aap Implantate AG20140—
+3K130614Bone Fragment and Fixation Plates, Screws and WashersLaura Cattabriga20142—
+3K113733Small and Large Fragments Osteosynthesis System NeofixNeoortho Produtos Ortopedicos S/A201211—
+4K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.20250—
+4K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+4K251620A.L.P.S. Proximal Humerus Plating SystemZimmer Biomet20250—
+4K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+4K242436Proximal Humerus Fixation SystemSkeletal Dynamics, Inc.20240—
+4K240613APTUS Elbow Dorsal Olecranon PlatesMedartis AG20244—
+4K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+4K230971APTUS® 3.5 TriLock Straight PlatesMedartis AG20232—
+4K223853Medartis APTUS® Ulna PlatesMedartis AG20235—
+4K201510Traufix osteosynthesis, osteotomy, and arthrodesis devicesFixier S.A. DE C.V.20220—
+4K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+4K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+4K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+4K142419Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A20148—
+5K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+5K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+5K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+5K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+5K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+5K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+5K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+5K234062APTUS Hand Scaphoid PlatesMedartis AG20243—
+5K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+5K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+5K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionMedartis AG20231—
+5K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+5K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+5K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+5K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+5K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+5K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+5K173746Activmotion RangeNewclip Technics20181—
+5K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+6K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+6K260810Anteralign LS coverplateTyber Medical, LLC20260—
+6K260761APTUS Clavicle System 2.8Medartis AG20260—
+6K260934TITAN Nail; APTUS K-Wire SystemMedartis AG20260—
+6K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+6K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+6K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+6K241539Activmotion SNewclip Technics20240—
+6K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+6K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+6K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+6K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+6K233017TM Plating SystemTyber Medical, LLC20231—
+6K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+6K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+6K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+7K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+7K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+7K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+8K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+9K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—