Cleared Traditional

Identity Shoulder System

K250848 · Zimmer, Inc. · Orthopedic

Jul 2025

Decision

104d

Days

Class 2

Risk

About This 510(k) Submission

K250848 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 July 2, 2025, 104 days after receiving the submission on March 20, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3670.

Submission Details

510(k) Number	K250848 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 20, 2025
Decision Date	July 02, 2025
Days to Decision	104 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