510(k) Report

Devices descending from K062216

501 later devices reach Peri-Loc Periarticular Locked Plating System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+1K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+1K173293EVOS Small Fragment Upper Extremity PlatesSmith & Nephew, Inc.201812—
+1K162078EVOS Small Fragment Plating SystemSmith & Nephew, Inc.2016261
+1K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc.2014462
+1K071563Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.2007495—
+2K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+2K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+2K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+2K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+2K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+2K233017TM Plating SystemTyber Medical, LLC20231—
+2K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+2K203405EVOS Large Fragment Plating SystemSmith & Nephew, Inc.20213—
+2K201918EVOS Large Fragment Plating SystemSmith & Nephew, Inc.202044
+2K201527EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm)Smith & Nephew, Inc.20208—
+2K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+2K190253EVOS Small Fragment Upper Extremity Plates Line AdditionsSmith & Nephew, Inc.20199—
+2K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—
+2K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+2K172262EVOS Small Fragment Plating SystemSmith & Nephew, Inc.20179—
+2K170457EVOS Small Fragment Lower Extremity PlatesSmith & Nephew, Inc.2017131
+2K170887EVOS Small Fragment Plating SystemSmith & Nephew, Inc.201713—
+2K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc.20160—
+2K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+2K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC201515—
+2K143050VLP Mini-Mod Small Bone Plating System 1.5mm Plates and ScrewsSmith & Nephew, Inc.20148—
+2K140357Oic Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20142—
+2K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.2014322
+2K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.201333—
+2K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009487—
+2K081106Peri-Loc Periarticular Locked Plating System Volar Distal Radius Locking Plate for the…Smith & Nephew, Inc.200834—
+3K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+3K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+3K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+3K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+3K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+3K240487EVOS Patella PlatesSmith & Nephew20240—
+3K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+3K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+3K223118OIC Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20231—
+3K213123EVOS Wrist Spanning PlateSmith & Nephew, Inc.20220—
+3K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+3K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+3K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+3K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+3K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+3K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+3K162153Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation SystemAscension Orthopedics20171—
+3K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+3K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+3K151407RECON systemNormed Medizin-Technik GmbH20154—
+3K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201579—
+3K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+3K140408Salvation Osteopenic ScrewWrightmedicaltechnologyinc20141—
+3K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+3K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+3K130479Ilizarov Drill Tip WiresSmith & Nephew, Inc.20136—
+3K124027Monster Screw SystemApogee Orthosolutions201341—
+3K122334Checkmate Small Bone Fusion SystemArthrosurface, Inc.20125—
+3K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc.2011161—
+3K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc.201169—
+3K093047Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc.2010511
+3K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010228—
+4K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+4K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+4K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+4K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+4K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+4K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+4K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+4K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+4K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+4K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+4K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+4K233919VariAx 2 Distal Radius SystemStryker GmbH20242—
+4K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes20244—
+4K230591TriLEAP Plating SystemCrossroads Extremity Systems20231—
+4K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+4K230053SimpliFix Hip SystemStabiliz Orthopaedics, Inc.20230—
+4K221342REDEMPTION Beaming SystemVilex, LLC20220—
+4K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+4K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+4K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+4K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+4K202326BESPA Charcot SystemBespa Global, LLC20210—
+4K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+4K210953SMART Taylor Spatial FrameSmith & Nephew, Inc.20212—
+4K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…Integra LifeSciences Corporation20210—
+4K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210—
+4K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+4K200062Foot and Ankle SystemLeith Medical, LLC20210—
+4K201253Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV…Smith & Nephew20205—
+4K200987LTJ Screws and WasherAzurmeds, Inc.20201—
+4K193368Smart Correction SystemWishbone Medical, Inc.202031
+4K201578DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20203—
+4K201149CoLink Plating SystemIn2bones USA, LLC20200—
+4K201556Intraosseous Fixation SystemExtremity Medical, LLC20200—
+4K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+4K193029Conquest FNSmith & Nephew, Inc.202010—