# K241666: EVOS Pelvic and Acetabular System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew
- Decided: Feb 19, 2025 after 254 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). 229 ancestors in all.
No later device cites it as a predicate yet.
0 of 230 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162078: EVOS Small Fragment Plating System, Smith & Nephew, Inc. (2016) Summary page 5.
- K140814: Evos Mini-Fragment Plating System, Smith & Nephew, Inc. (2014) Summary page 5.
- K060736: Smith & Nephew 6.5MM and 8.0MM Cannulated Screws, Smith & Nephew, Inc. (2006) Summary page 5.
- K170887: EVOS Small Fragment Plating System, Smith & Nephew, Inc. (2017) Summary page 5.
- K173293: EVOS Small Fragment Upper Extremity Plates, Smith & Nephew, Inc. (2018) Summary page 5.
- K122538: Acumed Pelvic Bone Plate System, Acumed, LLC (2012) Summary page 5.
- K063166: I.T.S. Pelvic Reconstruction System, I.T.S. Implantat-Technologie-Systeme GmbH (2006) Summary page 5.
- K210935: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix), I.T.S. GmbH (2022) Summary page 5.
- K221809: DePuy Synthes 3.5mm Intrapelvic Acetabular System, DePuy Synthes (2022) Summary page 5.
- K993106: Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories), Smith & Nephew, Inc. (1999) Summary page 5.

## Indications for use
The EVOS Pelvic and Acetabular System is indicated for fixation of fractures and/or disruptions of the pelvis and acetabulum in skeletally mature patients.

Source page: https://510kreport.com/device/K241666
Methodology: https://510kreport.com/methodology