510(k) Report

Devices descending from K083032

77 later devices reach Peri-Loc Bone Plating and Screw 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
+1K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+1K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+1K161665VLP Wrist Fracture SystemSmith & Nephew, Inc.201610—
+1K160633G3(TM) Active Plate (R) Small Fragment SystemGenesis Fracture Care, Inc.20160—
+1K142938G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20143—
+1K141121Axsos 3 TI Locking Plate SystemStryker Trauma AG201426—
+1K140357Oic Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20142—
+1K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc.2014462
+1K132296D-Rad Smart PackSmith & Nephew, Inc.2014114
+1K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.201333—
+2K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+2K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+2K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+2K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+2K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+2K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+2K233017TM Plating SystemTyber Medical, LLC20231—
+2K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+2K223118OIC Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20231—
+2K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+2K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+2K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+2K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+2K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—
+2K173746Activmotion RangeNewclip Technics20181—
+2K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+2K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc.20160—
+2K153379AxSOS 3TiStryker GmbH201625—
+2K152242G3¿ Active Plate® Large Fragment SystemGenesis Fracture Care, Inc.20151—
+2K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+2K150649G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20152—
+2K143050VLP Mini-Mod Small Bone Plating System 1.5mm Plates and ScrewsSmith & Nephew, Inc.20148—
+2K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.2014322
+3K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+3K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+3K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+3K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+3K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+3K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+3K240487EVOS Patella PlatesSmith & Nephew20240—
+3K241539Activmotion SNewclip Technics20240—
+3K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+3K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+3K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+3K213123EVOS Wrist Spanning PlateSmith & Nephew, Inc.20220—
+3K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+3K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+3K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+3K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+3K172350AxSOS 3 TiStryker GmbH201717—
+3K162439AxSOS 3 Ti; Stryker Plating SystemStryker GmbH201724—
+4K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+4K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+4K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+4K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+4K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+4K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+4K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+4K233919VariAx 2 Distal Radius SystemStryker GmbH20242—
+4K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+4K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+4K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+4K181091AxSOS 3 TiStryker GmbH201811—
+5K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+5K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+5K242436Proximal Humerus Fixation SystemSkeletal Dynamics, Inc.20240—
+5K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+5K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+5K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+5K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+5K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+5K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+6K260810Anteralign LS coverplateTyber Medical, LLC20260—
+6K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+6K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—