# K201918: EVOS Large Fragment Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Nov 16, 2020 after 129 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K962616 (1996). 42 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033669: Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws), Smith & Nephew, Inc. (2003) Summary page 4.
- K162078: EVOS Small Fragment Plating System, Smith & Nephew, Inc. (2016) Summary page 4.
- K061352: Peri-Loc Periarticular Locked Plating System for the Upper Extremity, Smith & Nephew, Inc. (2006) Summary page 4.
- K072818: Peri-Loc Periartricular LCK Pit Sys-Prox Fem Plates/Screws.Calbe Access, Smith & Nephew, Inc. (2007) Summary page 4.
- K092015: Peri-Loc Periarticular Locked Plating System, Smith & Nephew, Inc. (2009) Summary page 4.
- K993106: Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories), Smith & Nephew, Inc. (1999) Summary page 4.

## Most influential descendants
- K203405: EVOS Large Fragment Plating System (2021), 3 descendants of its own
- K213126: Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws (2022), 2 descendants of its own
- K252019: CurvaFix Low Profile System (2025), 0 descendants of its own
- K233396: Cannulated Screw System (2023), 0 descendants of its own

## Recalls of this device
- Nov 1, 2021 · Class II · Z-0366-2022: Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294
- Nov 1, 2021 · Class II · Z-0363-2022: Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294
- Nov 1, 2021 · Class II · Z-0365-2022: Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294
- Nov 1, 2021 · Class II · Z-0364-2022: Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294

## Indications for use
The EVOS Large Fragment Plating System is indicated for adult patients. It is indicated for fixation of long bone fractures.

Source page: https://510kreport.com/device/K201918
Methodology: https://510kreport.com/methodology