Cleared Traditional

Identity Shoulder System

K213856 · Zimmer, Inc. · Orthopedic

Sep 2022

Decision

279d

Days

Class 2

Risk

About This 510(k) Submission

K213856 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 September 15, 2022, 279 days after receiving the submission on December 10, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3670.

Submission Details

510(k) Number	K213856 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 10, 2021
Decision Date	September 15, 2022
Days to Decision	279 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