510(k) Report

Devices descending from K092812

55 later devices reach Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia Plates through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242988Genostis Osteosynthesis SystemGenostis AF20250—
+1K232394Internal Locking Plate and Screw Fixation SystemChangzhou Geasure Medical Apparatus and Instruments Co., Ltd.20230—
+1K193633APTUS® Ankle Trauma System 2.8/3.5Medartis AG202011—
+1K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand…Nebula Surgical Private Limited20193—
+1K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+1K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173—
+1K161747LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ®…Aap Implantate AG20160—
+1K153716GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.Gpc Medical, Ltd.201615—
+1K141680AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN…Auxein Medical20151—
+1K133675Aap Loqteq Distal Anterolateral Tibia Plate 3.5Aap Implantate AG20140—
+2K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+2K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+2K240613APTUS Elbow Dorsal Olecranon PlatesMedartis AG20244—
+2K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+2K230971APTUS® 3.5 TriLock Straight PlatesMedartis AG20232—
+2K223853Medartis APTUS® Ulna PlatesMedartis AG20235—
+2K201510Traufix osteosynthesis, osteotomy, and arthrodesis devicesFixier S.A. DE C.V.20220—
+2K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+2K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+2K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+3K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+3K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+3K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+3K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+3K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+3K234062APTUS Hand Scaphoid PlatesMedartis AG20243—
+3K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+3K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+3K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionMedartis AG20231—
+3K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+3K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+3K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+3K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+3K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+3K173746Activmotion RangeNewclip Technics20181—
+3K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+4K260810Anteralign LS coverplateTyber Medical, LLC20260—
+4K260761APTUS Clavicle System 2.8Medartis AG20260—
+4K260934TITAN Nail; APTUS K-Wire SystemMedartis AG20260—
+4K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+4K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+4K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+4K241539Activmotion SNewclip Technics20240—
+4K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+4K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+4K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+4K233017TM Plating SystemTyber Medical, LLC20231—
+4K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+4K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+4K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+5K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+5K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+5K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+6K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+7K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—