# K182799: Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Mar 8, 2019 after 157 days
- Product code: KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K911686 (1991). 106 ancestors in all.
No later device cites it as a predicate yet.
1 of 107 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140390: Titanium Versa-Dial Humeral Head Prosthesis, Biomet Manufacturing Corp (2014) Summary page 4.
- K140082: Aequalis (TM) Ascent (TM) Flex Shoulder System, Tornier S.A.S. (2014) Summary page 4.
- K071032: Arthrex Univers II Shoulder Prosthesis, Arthrex, Inc. (2007) Summary page 4.

## Indications for use
The Arthrex UNIVERS II Shoulder Prosthesis is indicated in replacement(s) when conditions including severe pain or significant disability resulting from degenerative, rheumatoid, traumatic disease, or injury of the glenohumeral joint; non-union humeral head fractures of long duration; irreducible 2- and 4-part proximal humeral fractures; avascular necrosis of the humeral head, or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable. The glenoid components are intended for cemented fixation in the joint and must only be used with appropriate bone cement. The Arthrex Titanium Humeral Head is indicated for patients with suspected cobalt alloy sensitivity. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head is not recommended for patients who lack suspected material sensitivity to cobalt alloy.

Source page: https://510kreport.com/device/K182799
Methodology: https://510kreport.com/methodology