Cleared Traditional

K233260 - Univers Revers CA Head and Adapter

K233260 is an FDA 510(k) clearance for Univers Revers CA Head and Adapter, manufactured by Arthrex, Inc.. The device is a Class 2 Orthopedic device with product code HSD cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K233260 · Arthrex, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2024
Decision
136d
Days
Class 2
Risk

K233260 is an FDA 510(k) clearance for the Univers Revers CA Head and Adapter. Classified as Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (product code HSD), Class II - Special Controls.

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on February 12, 2024 after a review of 136 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3690 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Arthrex, Inc. devices

FDA 510(k) Submission Details - K233260

510(k) Number K233260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 122d · This submission: 136d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HSD Device Classification - Class 2, Special Controls

Product Code HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3690
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

All 62
Devices cleared under the same product code (HSD) and FDA review panel - the closest regulatory comparables to K233260.
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