510(k) Report

Devices descending from K080522

113 later devices reach Synthes 3.5 MM LCP Distal Tibia T Plates through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261511Xpert AnkleNewclip Technics20260—
+1K242988Genostis Osteosynthesis SystemGenostis AF20250—
+1K243050TriMed Posterior Malleolus Fixation SystemTriMed, Inc.20240—
+1K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+1K190750DePuy Synthes Plates and Screws PortfolioDePuy Synthes20190—
+1K140357Oic Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20142—
+1K100240Orthopediatrics Pediloc Tibia Plate SystemOrthoPediatrics Corp.201013—
+1K092812Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia PlatesSynthes (Usa)201055—
+1K090666PediplatesOrthoPediatrics Corp.200915—
+1K081407Orthopediatrics Pediplates SystemOrthoPediatrics Corp.200865—
+2K232394Internal Locking Plate and Screw Fixation SystemChangzhou Geasure Medical Apparatus and Instruments Co., Ltd.20230—
+2K223118OIC Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20231—
+2K213572JuniOrtho Plating System™Orthofix Srl20220—
+2K200246JPS JuniOrtho Plating SystemOrthofix Srl20201—
+2K193633APTUS® Ankle Trauma System 2.8/3.5Medartis AG202011—
+2K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand…Nebula Surgical Private Limited20193—
+2K182704WishBone Guided Growth SystemWishbone Medical201901
+2K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+2K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173—
+2K161747LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ®…Aap Implantate AG20160—
+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—
+2K110959Orthopediatrics Blade Plate SystemOrthoPediatrics Corp.201123
+2K111086Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp.201171
+2K090440Hinge Pediatric Plating SystemPega Medical, Inc.20091—
+2K083286Orthopediatrics Pediloc Locking Plate SystemOrthoPediatrics Corp.2009605
+3K260323OrthoPediatrics® Locking Cannulated Blade Plate SystemOrthoPediatrics Corp.20260—
+3K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+3K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+3K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+3K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+3K240613APTUS Elbow Dorsal Olecranon PlatesMedartis AG20244—
+3K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+3K230971APTUS® 3.5 TriLock Straight PlatesMedartis AG20232—
+3K223853Medartis APTUS® Ulna PlatesMedartis AG20235—
+3K220190The GIRO Growth Modulation SystemPega Medical, Inc.20220—
+3K201510Traufix osteosynthesis, osteotomy, and arthrodesis devicesFixier S.A. DE C.V.20220—
+3K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+3K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc.201921
+3K181843MLP Special Locking Bone Plate SystemMaxxion Medical, LLC / Baumer SA20190—
+3K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+3K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+3K170704The Locking Pediatric Osteotomy Plate (LolliPOP) SystemPega Medical, Inc.20170—
+3K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+3K162307OrthoPediatrics Locking Proximal Femur System Cortical ScrewsOrthoPediatrics Corp.20161—
+3K140431Pediloc Fragment SystemOrthoPediatrics Corp.20141—
+3K120689Synthes 3.5 MM VA-LCP Proximal Tibia Plate SystemSynthes (USA) Products, LLC201228—
+3K093983Smple Plate and ScrewsBiomet Trauma (Aka Ebi, Lp)20100—
+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—
+4K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+4K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+4K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+4K250155Xpert KneeNewclip Technics20250—
+4K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+4K234062APTUS Hand Scaphoid PlatesMedartis AG20243—
+4K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+4K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+4K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionMedartis AG20231—
+4K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Bonebridge AG20237—
+4K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+4K213864Bonebridge Osteosynthesis Plating SystemBonebridge AG20228—
+4K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+4K202348External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc.20200—
+4K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+4K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+4K193617Precice® ScrewsNuvasive Specialized Orthopedics, Inc.20200—
+4K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+4K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+4K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+4K173746Activmotion RangeNewclip Technics20181—
+4K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+4K162124Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle…DePuy Synthes20176—
+4K141527Depuy Synthes Variable Angle Locking Hand SystemSynthes USA20157—
+5K260810Anteralign LS coverplateTyber Medical, LLC20260—
+5K260761APTUS Clavicle System 2.8Medartis AG20260—
+5K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+5K260934TITAN Nail; APTUS K-Wire SystemMedartis AG20260—
+5K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+5K253906Xpert HandNewclip Technics20260—
+5K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+5K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG20251—
+5K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+5K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+5K242814Tandry Q-Locking Plate SystemMicroware Precision Co., Ltd.20240—
+5K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+5K240318SITTER 3.5mm Versatile SystemBonebridge AG20244—
+5K241539Activmotion SNewclip Technics20240—
+5K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+5K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+5K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+5K233017TM Plating SystemTyber Medical, LLC20231—
+5K231333STRETTO™ Cable SystemGlobus Medical, Inc.20230—
+5K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+5K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+5K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+5K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+5K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+5K172975DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20182—