Cleared Traditional

Univers Revers CA Head and Adapter

K233260 · Arthrex, Inc. · Orthopedic
Feb 2024
Decision
136d
Days
Class 2
Risk

About This 510(k) Submission

K233260 is an FDA 510(k) clearance for the Univers Revers CA Head and Adapter, a Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (Class II — Special Controls, product code HSD), submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on February 12, 2024, 136 days after receiving the submission on September 29, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3690.

Submission Details

510(k) Number K233260 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2023
Decision Date February 12, 2024
Days to Decision 136 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HSD — Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3690

Similar Devices — HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

All 70
Univers Revers Humeral Cup Implant
K221232 · Arthrex, Inc. · May 2022
AGILON? XO Shoulder Replacement System
K191433 · Implantcast GmbH · Nov 2020
Biocore9 Humeral Resurfacing System
K193122 · Biocore9, LLC · May 2020
OVOMotion Shoulder Arthroplasty System
K173964 · Arthrosurface, Inc. · Apr 2018
Arthrex Univers Revers Shoulder Prosthesis System
K161782 · Arthrex, Inc. · Nov 2016
Anatomical Shoulder Domelock Dome centric
K161620 · Zimmer GmbH · Nov 2016