Cleared Traditional

INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid

K230831 · Depuy Ireland UC · Orthopedic

Nov 2023

Decision

231d

Days

Class 2

Risk

About This 510(k) Submission

K230831 is an FDA 510(k) clearance for the INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid, a Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented (Class II — Special Controls, product code MBF), submitted by Depuy Ireland UC (Ringaskiddy, IE). The FDA issued a Cleared decision on November 13, 2023, 231 days after receiving the submission on March 27, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3670.

Submission Details

510(k) Number	K230831 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 27, 2023
Decision Date	November 13, 2023
Days to Decision	231 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MBF — Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3670