Cleared Traditional

OR3O Dual Mobility System

K242375 · Smith & Nephew, Inc. · Orthopedic
Oct 2024
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K242375 is an FDA 510(k) clearance for the OR3O Dual Mobility System, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II — Special Controls, product code LPH), submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on October 7, 2024, 59 days after receiving the submission on August 9, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3358.

Submission Details

510(k) Number K242375 FDA.gov
FDA Decision Cleared SESE
Date Received August 09, 2024
Decision Date October 07, 2024
Days to Decision 59 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code LPH — Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3358

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