# K071032: Arthrex Univers II Shoulder Prosthesis

- Pathway: 510(k) (Special)
- Applicant: Arthrex, Inc.
- Decided: Aug 20, 2007 after 131 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: 1 generation back to K010124 (2001). 1 ancestor in all.
21 later devices descend from it; 7 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010124: Arthrex Univers 30 Shoulder Prosthesis, Arthrex, Inc. (2001) Summary page 1.

## Most influential descendants
- K183194: Arthrex Eclipse Shoulder Prosthesis System (2019), 8 descendants of its own
- K103466: Arthrex Univers II Shoulder Prosthesis (2010), 5 descendants of its own
- K083435: Arthrex Univers II Shoulder Pegged Glenoid (2009), 5 descendants of its own
- K131633: Arthrex Univers Apex (2013), 4 descendants of its own
- K120044: Arthrex Universii XL Glenoid-Pegged, Arthrex Univers II XL Glenoid-Keeled (2012), 4 descendants of its own

## Indications for use
The Arthrex Univers II Shoulder Prosthesis is indicated in replacements(s) when conditions include 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 designed for cemented fixation in the joint and must only be used with an appropriate bone cement.

Source page: https://510kreport.com/device/K071032
Methodology: https://510kreport.com/methodology