Cleared Traditional

Identity Revision Humeral Stems

K251098 · Zimmer, Inc. · Orthopedic

Aug 2025

Decision

123d

Days

Class 2

Risk

About This 510(k) Submission

K251098 is an FDA 510(k) clearance for the Identity Revision Humeral Stems, 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 August 11, 2025, 123 days after receiving the submission on April 10, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3670.

Submission Details

510(k) Number	K251098 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 10, 2025
Decision Date	August 11, 2025
Days to Decision	123 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