Cleared Traditional

INHANCE INTACT?

K243248 · Depuy Ireland UC · Orthopedic

Dec 2024

Decision

73d

Days

Class 2

Risk

About This 510(k) Submission

K243248 is an FDA 510(k) clearance for the INHANCE INTACT?, a Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained (Class II — Special Controls, product code PKC), submitted by Depuy Ireland UC (Ringaskiddy, IE). The FDA issued a Cleared decision on December 23, 2024, 73 days after receiving the submission on October 11, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K243248 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 11, 2024
Decision Date	December 23, 2024
Days to Decision	73 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	PKC — Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3660
Definition	Replacement Of The Humeral Head For Total Anatomic Shoulder Arthroplasty