510(k) Report

Devices descending from K013248

116 later devices reach Synthes LCP Distal Tibia Plates through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230507Zimed Distal Medial Tibial Plate and Screw SystemZimed Medikal20240—
+1K223150APS Metal Plate & Screw SystemA Plus Biotechnology Co., Ltd.20230—
+1K213059Tibia and Fibula SystemAuxein Medical Private Limited20232—
+1K201229Intai Anatomic Locking Plate and Screw SystemIntai Technology Corporation20220—
+1K193633APTUS® Ankle Trauma System 2.8/3.5Medartis AG202011—
+1K192619Pitkar Locked Plating SystemS.H.Pitkar Orthotools Pvt., Ltd.20200—
+1K190750DePuy Synthes Plates and Screws PortfolioDePuy Synthes20190—
+1K171904Tandry Locking Plate SystemMicroware Precision Co., Ltd.201811—
+1K170313ARIX Ankle Distal Tibia SystemJeil Medical Corporation20172—
+1K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+1K161747LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ®…Aap Implantate AG20160—
+1K141121Axsos 3 TI Locking Plate SystemStryker Trauma AG201426—
+1K133541Emerge Medical Small and Large Non-Locking Fragment Plate SystemEmerge Medical20140—
+1K122936Ankle Trauma SystemOrthopro, LLC20131—
+1K113601Aap Loqteq Distal Medial Tibia Plate 3.5 SystemAap Implantate AG20120—
+1K092812Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia PlatesSynthes (Usa)201055—
+1K090666PediplatesOrthoPediatrics Corp.200915—
+1K063672Fibula Plate Prolock with Angular StabilityI.T.S. Implantat-Technologie-Systeme GmbH2007251
+1K052011Pilonplate with Angular StabilityI.T.S. Implantat-Technologie-Systeme GmbH200511
+1K042237Ebi Periarticular Plating SystemEbi, L.P.2004310
+2K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+2K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+2K242988Genostis Osteosynthesis SystemGenostis AF20250—
+2K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+2K242814Tandry Q-Locking Plate SystemMicroware Precision Co., Ltd.20240—
+2K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+2K240181Clavicle and Scapula SystemAuxein Medical Pvt., Ltd.20240—
+2K240613APTUS Elbow Dorsal Olecranon PlatesMedartis AG20244—
+2K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+2K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+2K232394Internal Locking Plate and Screw Fixation SystemChangzhou Geasure Medical Apparatus and Instruments Co., Ltd.20230—
+2K230690Tandry Locking Plate SystemMicroware Precision Co., Ltd.20231—
+2K230971APTUS® 3.5 TriLock Straight PlatesMedartis AG20232—
+2K223853Medartis APTUS® Ulna PlatesMedartis AG20235—
+2K223118OIC Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20231—
+2K220359Tandry Compression Screw SystemMicroware Precision Co., Ltd.20220—
+2K202971DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company20212—
+2K202912ARIX Ankle Distal Tibia SystemJeil Medical Corporation20201—
+2K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+2K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand…Nebula Surgical Private Limited20193—
+2K182704WishBone Guided Growth SystemWishbone Medical201901
+2K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+2K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173—
+2K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+2K153379AxSOS 3TiStryker GmbH201625—
+2K153716GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.Gpc Medical, Ltd.201615—
+2K141680AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN…Auxein Medical20151—
+2K133675Aap Loqteq Distal Anterolateral Tibia Plate 3.5Aap Implantate AG20140—
+2K100240Orthopediatrics Pediloc Tibia Plate SystemOrthoPediatrics Corp.201013—
+2K092078Optilock Periarticular PlatingBiomet Trauma20092—
+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—
+3K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+3K234062APTUS Hand Scaphoid PlatesMedartis AG20243—
+3K233531OIC FLEX-FIX™ SystemOrthopaedic Implant Company20240—
+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—
+3K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+3K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+3K212601DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company20220—
+3K201510Traufix osteosynthesis, osteotomy, and arthrodesis devicesFixier S.A. DE C.V.20220—
+3K213572JuniOrtho Plating System™Orthofix Srl20220—
+3K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+3K200246JPS JuniOrtho Plating SystemOrthofix Srl20201—
+3K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+3K172350AxSOS 3 TiStryker GmbH201717—
+3K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+3K162439AxSOS 3 Ti; Stryker Plating SystemStryker GmbH201724—
+3K140018TSP Hip Fracture Plating SystemBiomet, Inc.201412
+3K110959Orthopediatrics Blade Plate SystemOrthoPediatrics Corp.201123
+3K111086Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp.201171
+4K260810Anteralign LS coverplateTyber Medical, LLC20260—
+4K260761APTUS Clavicle System 2.8Medartis AG20260—
+4K260323OrthoPediatrics® Locking Cannulated Blade Plate SystemOrthoPediatrics Corp.20260—
+4K260934TITAN Nail; APTUS K-Wire SystemMedartis AG20260—
+4K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+4K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+4K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+4K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+4K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+4K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+4K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+4K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+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—
+4K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+4K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+4K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+4K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+4K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc.201921
+4K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+4K181091AxSOS 3 TiStryker GmbH201811—
+4K173746Activmotion RangeNewclip Technics20181—
+4K173826THP Hip Fracture Plating SystemBiomet, Inc.20180—
+4K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+4K170704The Locking Pediatric Osteotomy Plate (LolliPOP) SystemPega Medical, Inc.20170—
+4K162307OrthoPediatrics Locking Proximal Femur System Cortical ScrewsOrthoPediatrics Corp.20161—