# K190253: EVOS Small Fragment Upper Extremity Plates Line Additions

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Mar 11, 2019 after 32 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). 46 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173293: EVOS Small Fragment Upper Extremity Plates, Smith & Nephew, Inc. (2018) Summary page 4.

## 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 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/K190253
Methodology: https://510kreport.com/methodology