Cleared Traditional

Icona Hip Stem

K241472 · Corin U.S.A. Limited · Orthopedic

Oct 2024

Decision

132d

Days

Class 2

Risk

About This 510(k) Submission

K241472 is an FDA 510(k) clearance for the Icona Hip Stem, a Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (Class II — Special Controls, product code MEH), submitted by Corin U.S.A. Limited (Tampa, US). The FDA issued a Cleared decision on October 3, 2024, 132 days after receiving the submission on May 24, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K241472 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 24, 2024
Decision Date	October 03, 2024
Days to Decision	132 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MEH — Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3353