# K181533: EVOS Wrist Fracture Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Aug 9, 2018 after 59 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K962616 (1996). 112 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 122 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161665: VLP Wrist Fracture System, Smith & Nephew, Inc. (2016) Summary page 5.
- K132296: D-Rad Smart Pack, Smith & Nephew, Inc. (2014) Summary page 5.
- K993106: Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories), Smith & Nephew, Inc. (1999) Summary page 5.
- K162078: EVOS Small Fragment Plating System, Smith & Nephew, Inc. (2016) Summary page 5.
- K043185: Synthes 3.5MM Cortex Screws, Synthes (Usa) (2005) Summary page 5.
- K140814: Evos Mini-Fragment Plating System, Smith & Nephew, Inc. (2014) Summary page 5.
- K132886: Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System, Smith & Nephew, Inc. (2014) Summary page 5.

## Most influential descendants
- K210837: Smith & Nephew Plates and Screws (2021), 7 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
- K233017: TM Plating System (2023), 1 descendant of its own
- K261207: Exalta Proximal Tibia Plating System (2026), 0 descendants of its own
- K253713: Arthrex Variable Angle (VA) Proximal Tibia Plating System (2026), 0 descendants of its own

## Indications for use
The EVOS Wrist Plating System is indicated for adult and pediatric patients, as well as patients with osteopenic bone. It is indicated for fixation of fractures, malunions, and osteotomies involving the radius and ulna.

Source page: https://510kreport.com/device/K181533
Methodology: https://510kreport.com/methodology