Cleared Traditional

Arthrex Univers Apex OptiFit Humeral Stem

K230513 · Arthrex, Inc. · Orthopedic

Sep 2023

Decision

214d

Days

Class 2

Risk

About This 510(k) Submission

K230513 is an FDA 510(k) clearance for the Arthrex Univers Apex OptiFit Humeral Stem, a Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (Class II — Special Controls, product code KWS), submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on September 26, 2023, 214 days after receiving the submission on February 24, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K230513 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 24, 2023
Decision Date	September 26, 2023
Days to Decision	214 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	KWS — Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3660