Cleared Traditional

EVOS Pelvic and Acetabular System

K241666 · Smith & Nephew · Orthopedic
Feb 2025
Decision
254d
Days
Class 2
Risk

About This 510(k) Submission

K241666 is an FDA 510(k) clearance for the EVOS Pelvic and Acetabular System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Smith & Nephew (Memphus, US). The FDA issued a Cleared decision on February 19, 2025, 254 days after receiving the submission on June 10, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K241666 FDA.gov
FDA Decision Cleared SESE
Date Received June 10, 2024
Decision Date February 19, 2025
Days to Decision 254 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HRS — Plate, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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