# K140814: Evos Mini-Fragment Plating System

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: May 7, 2014 after 36 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K962616 (1996). 105 ancestors in all.
32 later devices descend from it; 11 cite it directly.
0 of 138 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132886: Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System, Smith & Nephew, Inc. (2014) Summary page 1.
- K123055: Smith & Nephew, Inc Screw and Plate System Instrumentation, Smith & Nephew, Inc. (2013) Summary page 2.
- K090675: Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories, Smith & Nephew, Inc. (2009) Summary page 2.

## Most influential descendants
- K163361: ANTHEM™ Fracture System (2017), 14 descendants of its own
- K173166: ANTHEM Fracture System (2017), 11 descendants of its own
- K180554: ANTHEM Fracture System (2018), 10 descendants of its own
- K181533: EVOS Wrist Fracture Plating System (2018), 9 descendants of its own
- K202496: ANTHEM Fracture System (2020), 8 descendants of its own

## Recalls of this device
- Aug 24, 2020 · Class II · Z-2945-2020: Multiple or incorrect expiration dates were provided on the affected designation labels.
- Nov 29, 2017 · Class II · Z-0408-2018: One lot of EVOS 2.4MM Flex Plate 6 Hole packaging contained templates.

## Indications for use
The Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System is indicated for adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System is indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bones and fragments. This system is also indicated for non-load bearing stabilization and reduction of bone fragments in long bones. Bone plates and bone screws from the Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System are for single use only.

Source page: https://510kreport.com/device/K140814
Methodology: https://510kreport.com/methodology