510(k) Report

Devices descending from K000684

965 later devices reach Small Fragment Dynamic Compression Locking (DCL) System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+2K230971APTUS® 3.5 TriLock Straight PlatesMedartis AG20232—
+2K230204ALPHALOK Plating SystemVilex, LLC20230—
+2K223853Medartis APTUS® Ulna PlatesMedartis AG20235—
+2K230141LOQTEQ® VA Elbow Plates 2.7/3.5 SystemAap Implantate AG20230—
+2K221558ALPHALOK Plating SystemVilex, LLC20222—
+2K213108Humerus & Ulna SystemAuxein Medical Private Limited20221—
+2K222282HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating SystemHospital Equipment Manufacturing Company20221—
+2K213014Varixis Elbow SystemAuxein Medical Private Limited20220—
+2K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+2K213864Bonebridge Osteosynthesis Plating SystemBonebridge AG20228—
+2K221395Footmotion Plating SystemNewclip Technics20220—
+2K212601DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company20220—
+2K201229Intai Anatomic Locking Plate and Screw SystemIntai Technology Corporation20220—
+2K213005Apollo Ankle Fracture Plating SystemGlw Medical, Inc.20221—
+2K201510Traufix osteosynthesis, osteotomy, and arthrodesis devicesFixier S.A. DE C.V.20220—
+2K202803Activmotion S DTONewclip Technics20210—
+2K213214Xpert WristNewclip Technics20210—
+2K203002SALGINA 2.5mm Volar Distal Radius System, CASCELLA 3.5mm Superior Clavicle System…Bonebridge AG20219—
+2K210490ChM 4.5mm Cortical screwsChm Sp. Z O.O.20210—
+2K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+2K211435PAO Cortical ScrewMedacta International S.A.20210—
+2K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210—
+2K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+2K211051DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System)DePuy Synthes20211—
+2K200062Foot and Ankle SystemLeith Medical, LLC20210—
+2K203405EVOS Large Fragment Plating SystemSmith & Nephew, Inc.20213—
+2K201259ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating SystemWrightmedicaltechnologyinc20210—
+2K203414DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle…DePuy Synthes20201—
+2K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+2K201918EVOS Large Fragment Plating SystemSmith & Nephew, Inc.202044
+2K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+2K192003Auxein Nailing SystemAuxein Medical Private Limited20202—
+2K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+2K200367Distal Humerus Plating SystemSkeletal Dynamics, Inc.20201—
+2K192619Pitkar Locked Plating SystemS.H.Pitkar Orthotools Pvt., Ltd.20200—
+2K192984APTUS Clavicle SystemMedartis AG20206—
+2K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—
+2K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+2K191711ORTHOLOC™ SPS Shoulder Plating SystemTornier, Inc.20190—
+2K182704WishBone Guided Growth SystemWishbone Medical201901
+2K181843MLP Special Locking Bone Plate SystemMaxxion Medical, LLC / Baumer SA20190—
+2K180541DePuy Synthes 2.0 mm Quick Insertion ScrewsSynthes USA Products, LLC20188—
+2K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20184—
+2K182466AOS Calcaneal Plating SystemAdvanced Orthopaedic Solutions20180—
+2K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+2K180972ARIX Clavicle SystemJeil Medical Corporation20181—
+2K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—
+2K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+2K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+2K173746Activmotion RangeNewclip Technics20181—
+2K173641Activ AnkleNewclip Technics20183—
+2K173293EVOS Small Fragment Upper Extremity PlatesSmith & Nephew, Inc.201812—
+2K171372Alians Elbow Locking Plating SystemNewclip Technics20180—
+2K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+2K172008ARIX Humerus SystemJeil Medical Corporation20173—
+2K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+2K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+2K170704The Locking Pediatric Osteotomy Plate (LolliPOP) SystemPega Medical, Inc.20170—
+2K172262EVOS Small Fragment Plating SystemSmith & Nephew, Inc.20179—
+2K162507Arzzt 3.5 / 4.5 Small & Large Fragments SystemTruemed Group, LLC20173—
+2K170313ARIX Ankle Distal Tibia SystemJeil Medical Corporation20172—
+2K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+2K170843Alians Fragment SpecificNewclip Technics20171—
+2K163425NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS…Narang Medical USA Corporation20170—
+2K162898Olecranon Plating SystemMiami Device Solutions, LLC20171—
+2K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Synthes USA Products, LLC201733—
+2K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc.20161—
+2K161747LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ®…Aap Implantate AG20160—
+2K161665VLP Wrist Fracture SystemSmith & Nephew, Inc.201610—
+2K161703LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, WasherAap Implantate AG20160—
+2K161913AOS Small Fragment Plating SystemAdvanced Orthopaedic Solutions, Inc. (Aos)20162—
+2K160633G3(TM) Active Plate (R) Small Fragment SystemGenesis Fracture Care, Inc.20160—
+2K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+2K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+2K152187MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete…Merete Medical GmbH20160—
+2K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+2K151407RECON systemNormed Medizin-Technik GmbH20154—
+2K151057WASTON Metallic Bone Plate and Screw SystemsChangzhou Waston Medical Appliance Co., Ltd.20150—
+2K142943Metallic Locking Bone Plate and ScrewCanwell Medical Co., Ltd.20150—
+2K150981SMV Scientific Bone ScrewsSmv Scientific20156—
+2K143385Acumed Ankle Plating SystemAcumed, LLC201523—
+2K150099Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)Synthes (USA) Products, LLC201514—
+2K141493Proximal Humerus Plating SystemMiami Device Solutions201571
+2K143394Acumed Small Fragment Base SetAcumed, LLC201518—
+2K142502Alians Ulna Locking Plating SystemNewclip Technics20142—
+2K142938G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20143—
+2K141949Cortical Screw 3.5, T15, Self-Tapping, Titanium, Cortical Screw 4.5, T25, Self Tapping…Aap Implantate AG20140—
+2K140508Zimmer Plates and Screws System (ZPS)- Non-Sterile Plates and ScrewsZimmer, Inc.201414—
+2K141204Variax 2 One Third Tubular Plating SystemStryker Trauma AG20147—
+2K141121Axsos 3 TI Locking Plate SystemStryker Trauma AG201426—
+2K140357Oic Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20142—
+2K140565Variax 2 Compression Plating SystemStryker Trauma AG20143—
+2K140259Variax Clavicle Hook PlateStryker Trauma AG201413—
+2K140119Emerge Medical Periarticular and Locking Large Fragment SystemEmerge Medical20141—
+2K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH201410—
+2K133536Emerge Medical Bone Plate SystemEmerge Medical20140—
+2K133691Extrimilock Ankle Plating SystemOsteomed LP201410—
+2K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc.2014462
+2K132296D-Rad Smart PackSmith & Nephew, Inc.2014114
+2K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—