Cleared Traditional

INHANCE? Shoulder System, Sterile Single Use Instrumentation

K231516 · Depuy Ireland UC · Orthopedic

Jul 2023

Decision

57d

Days

Class 2

Risk

About This 510(k) Submission

K231516 is an FDA 510(k) clearance for the INHANCE? Shoulder System, Sterile Single Use Instrumentation, 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 July 21, 2023, 57 days after receiving the submission on May 25, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3670.

Submission Details

510(k) Number	K231516 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 25, 2023
Decision Date	July 21, 2023
Days to Decision	57 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