Cleared Traditional

Identity Shoulder System

K240876 · Zimmer, Inc. · Orthopedic

Jun 2024

Decision

75d

Days

Class 2

Risk

About This 510(k) Submission

K240876 is an FDA 510(k) clearance for the Identity Shoulder System, a Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented (Class II — Special Controls, product code MBF), submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on June 12, 2024, 75 days after receiving the submission on March 29, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3670.

Submission Details

510(k) Number	K240876 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 29, 2024
Decision Date	June 12, 2024
Days to Decision	75 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