# K170457: EVOS Small Fragment Lower Extremity Plates

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jun 14, 2017 after 119 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: 8 generations back to K962616 (1996). 30 ancestors in all.
13 later devices descend from it; 3 cite it directly.
0 of 44 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.
- K071563: Peri-Loc Periarticular Locked Plating System, Smith & Nephew, Inc. (2007) Summary page 4.

## Most influential descendants
- 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
- K201527: EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm) (2020), 8 descendants of its own
- 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

## Recalls of this device
- Sep 6, 2026 · Not classified · Z-0318-2027: Incorrect labeling; 3.5MM Partial Articular Lateral Proximal Tibia Plate 6 hole Left 91MM implant labeled and lasered etched as as 3.5MM Lateral Proximal Tibia Plate 6 hole left 91mm implant

## 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. The EVOS Partial Articular and Anti-Glide plates are indicated for the treatment of partial articular fractures of the distal and proximal tibia (AO/OTA Fracture Classification Type B), and for fracture fixation of the fibula.

Source page: https://510kreport.com/device/K170457
Methodology: https://510kreport.com/methodology