# K162078: EVOS Small Fragment Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Nov 18, 2016 after 114 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K962616 (1996). 32 ancestors in all.
26 later devices descend from it; 9 cite it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993106: Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories), Smith & Nephew, Inc. (1999) Summary page 4.
- K000684: Small Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 4.
- K033669: Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws), Smith & Nephew, Inc. (2003) Summary page 4.
- K062216: Peri-Loc Periarticular Locked Plating System, Smith & Nephew, Inc. (2006) Summary page 4.
- K082516: Peri-Loc Periarticular Locked Plating System Hexalobular Bone Screws, Smith & Nephew, Inc. (2008) Summary page 4.

## Most influential descendants
- K170887: EVOS Small Fragment Plating System (2017), 13 descendants of its own
- K173293: EVOS Small Fragment Upper Extremity Plates (2018), 12 descendants of its own
- K190253: EVOS Small Fragment Upper Extremity Plates Line Additions (2019), 9 descendants of its own
- K181533: EVOS Wrist Fracture Plating System (2018), 9 descendants of its own
- K172262: EVOS Small Fragment Plating System (2017), 9 descendants of its own

## Recalls of this device
- Oct 25, 2021 · Class II · Z-0265-2022: The labels on the packages of screws were switched.

## Indications for use
The EVOS Small Fragment Plating System is indicated for adult and pediatric patients, as well as patients with osteopenic bone. It is indicated for fixation of small and long bone fractures, including, but not limited to, those of the tibia, fibula, femur, humerus, ulna, radius, pelvis, acetabulum, metacarpals, metatarsals, and clavicle.

Source page: https://510kreport.com/device/K162078
Methodology: https://510kreport.com/methodology