Cleared Traditional

CORAIL Cemented Femoral Stem

K231526 · Depuy Ireland UC · Orthopedic

Dec 2023

Decision

207d

Days

Class 2

Risk

About This 510(k) Submission

K231526 is an FDA 510(k) clearance for the CORAIL Cemented Femoral Stem, a Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (Class II — Special Controls, product code KWY), submitted by Depuy Ireland UC (Co. Cork, IE). The FDA issued a Cleared decision on December 19, 2023, 207 days after receiving the submission on May 26, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3390.

Submission Details

510(k) Number	K231526 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 26, 2023
Decision Date	December 19, 2023
Days to Decision	207 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	KWY — Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3390