510(k) Report

Devices descending from K162078

26 later devices reach EVOS Small Fragment Plating System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+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
+1K203405EVOS Large Fragment Plating SystemSmith & Nephew, Inc.20213—
+1K201918EVOS Large Fragment Plating SystemSmith & Nephew, Inc.202044
+1K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—
+1K173293EVOS Small Fragment Upper Extremity PlatesSmith & Nephew, Inc.201812—
+1K172262EVOS Small Fragment Plating SystemSmith & Nephew, Inc.20179—
+1K170887EVOS Small Fragment Plating SystemSmith & Nephew, Inc.201713—
+2K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+2K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+2K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+2K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+2K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+2K233017TM Plating SystemTyber Medical, LLC20231—
+2K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+2K213123EVOS Wrist Spanning PlateSmith & Nephew, Inc.20220—
+2K201527EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm)Smith & Nephew, Inc.20208—
+2K190253EVOS Small Fragment Upper Extremity Plates Line AdditionsSmith & Nephew, Inc.20199—
+3K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+3K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+3K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+3K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+4K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+4K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+4K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—