# K240487: EVOS Patella Plates

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew
- Decided: Sep 3, 2024 after 196 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: 14 generations back to K962616 (1996). 190 ancestors in all.
No later device cites it as a predicate yet.
0 of 191 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140814: Evos Mini-Fragment Plating System, Smith & Nephew, Inc. (2014) Summary page 5.
- K210408: DePuy Synthes Variable Angle Locking Patella Plating System, Synthes (USA) Products, LLC (2021) Summary page 5.
- K203834: Arthrex Patella SuturePlates, Arthrex, Inc. (2021) Summary page 5.

## Indications for use
The EVOS Mini Plating System, excluding EVOS Patella Plates, is indicated for patients 12 — 21 and those over 21 years of age, as well as patients with osteopenic bone. The Smith & Nephew EVOS Mini Plating System is indicated for fracture fixation or reduction of small bones and small bone fragments. This system is also indicated for non-load bearing stabilization and reduction of bone fragments in long bones. The EVOS Patella Plates are indicated for the fixation and stabilization of patellar fractures for patients over 21 years of age.

Source page: https://510kreport.com/device/K240487
Methodology: https://510kreport.com/methodology