510(k) Report

Devices descending from K915818

230 later devices reach Synthes (R) Titanium Small Reconstruction Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+1K993465Depuy Ace Calcaneal Peri-Articular PlateDepuy, Inc.200042—
+1K990094Kmi Wrist Fusion SystemKinetikos Medical, Inc.1999127—
+1K981775Depuy Ace Timax Calcaneal Peri-Articular PlateDepuy Ace Medical Co.1998112—
+2K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+2K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc.2012117
+2K112169Aptus Wrist Arthrodesis PlatesMedartis AG20128—
+2K1032432.4MM VA-LCP Intercarpal Fusion SystemSynthes (Usa)2011187
+2K051642FR.O.H. Calcaneus Repair SystemI.T.S. Implantat-Technologie-Systeme GmbH2005281
+2K041786Calcamea PlateNew Deal, S.A.200413—
+2K033639Acumed Lower Extremity Congruent Plate SystemAcumed, LLC20049810
+2K991873Kmi Wrist Fusion SystemKinetikos Medical, Inc.1999117—
+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—
+3K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+3K242973CanMINI Hand and Foot SystemCanwell Medical Co., Ltd.20250—
+3K243761A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics20250—
+3K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+3K192297APTUS Wrist Arthrodesis PlatesMedartis AG20197—
+3K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+3K131380Acumed Totalw Rist Fusion Plating SystemAcumed, LLC20130—
+3K123562Flower Small and Medium Bone ImplantsFlower Orthopedics Corporation2013142
+3K100123Acumed Wrist Arthrodesis Plate SystemAcumed, LLC20101—
+3K093163Integra Total Wrist Fusion SystemIntegra LifeSciences Corporation20090—
+3K090582Calcaneal Fracture Plate SystemTornier, Inc.200912—
+3K073375Newdeal Tibiaxys SystemNewdeal Sas2008732
+3K063831Basal Dorsal PlatesNewdeal Sas20070—
+3K063672Fibula Plate Prolock with Angular StabilityI.T.S. Implantat-Technologie-Systeme GmbH2007251
+3K063166I.T.S. Pelvic Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH200692
+3K060474Lisfranc PlateNew Deal, S.A.20061—
+3K060476Lapidus PlateNew Deal, S.A.20061—
+3K060156Straight Plate with Angular Stability & Screw SystemI.T.S. Implantat-Technologie-Systeme GmbH2006272
+3K050681Omnitech System & Easy Lock Osteosystem with Xtremities PlatesTriMed, Inc.200592—
+3K030881Avanta Carpal Fusion Plating SystemAvanta Orthopaedics, Inc.20030—
+3K021321Wrist Fusion PlateAcu Med, Inc.2002113—
+4K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+4K252061Distal Xtremities SystemTriMed, Inc.20250—
+4K243943TriMed® Compression ScrewsTriMed, Inc.20252—
+4K250948TriMed Fusion Cup SystemTriMed, Inc.20250—
+4K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+4K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+4K232144Sterile Products of the APTUS SystemMedartis AG20233—
+4K223853Medartis APTUS® Ulna PlatesMedartis AG20235—
+4K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+4K202803Activmotion S DTONewclip Technics20210—
+4K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…Integra LifeSciences Corporation20210—
+4K202589APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS…Medartis AG202061
+4K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+4K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+4K170687Flower Bone Screw SetFlower Orthopedics Corporation20170—
+4K152306MotoBand¿ CP Implant SystemCrossroads Extremity Systems, LLC20157—
+4K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+4K142306Flower Upper Extremity Plating SetFlower Orthopedics Corporation20140—
+4K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+4K132898A.L.P.S. Calcaneal Plating SystemBiomet Manufacturing Corp201311—
+4K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—
+4K132248Flower Bone Screw SetFlower Orthopedics Corporation20131—
+4K131657Flower Small and Medium Implant SetFlower Orthopedics Corporation2013111
+4K130008Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous…I.T.S. GmbH201311
+4K122538Acumed Pelvic Bone Plate SystemAcumed, LLC201241
+4K121425Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc201253—
+4K112794Eos Small Bone Fixation SystemTriMed, Inc.201294
+4K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited2012581
+4K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited20118—
+4K111266Easylock OsteosystemTriMed, Inc.20110—
+4K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc.201169—
+4K093868I.T.S. LRS Locking Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH201011
+4K100176Ascension Ankle Fusion Plate SystemAscension Orthopedics, Inc.201056—
+4K092670Biodrive Micro Screw SystemEbi,Llc D/B/A Biomet Trauma200968—
+4K063820Lisfranc PlateNew Deal, S.A.20070—
+4K070241Modification to Lapidus PlateNew Deal, S.A.200701
+5K262344Large Compression ScrewsTriMed, Inc.20260—
+5K261241TriMed Compression ScrewsTriMed, Inc.20260—
+5K260934TITAN Nail; APTUS K-Wire SystemMedartis AG20260—
+5K260274Airlock® Ankle Plating SystemNovastep SAS20260—
+5K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+5K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+5K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+5K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+5K234062APTUS Hand Scaphoid PlatesMedartis AG20243—
+5K240212COGNiTiON™ Staple SystemOrtho Solutions UK, Ltd.20240—
+5K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionMedartis AG20231—
+5K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+5K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+5K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+5K221346Stryker VariAx 2 MIS CalcaneusStryker GmbH20220—
+5K221395Footmotion Plating SystemNewclip Technics20220—
+5K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+5K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+5K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+5K202307Activ FuseNewclip Technics20200—
+5K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+5K190166TriMed Nitinol Staple SystemTriMed, Inc.20190—
+5K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—
+5K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+5K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+5K171808TDM Plate and Screw SystemTdm Co., Ltd.20186—
+5K173710MotoBAND CP Implant SystemCrossroads Extremity Systems, LLC201841
+5K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+5K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc201712—