# K103466: Arthrex Univers II Shoulder Prosthesis

- Pathway: 510(k) (Special)
- Applicant: Arthrex, Inc.
- Decided: Dec 22, 2010 after 28 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: 2 generations back to K010124 (2001). 2 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071032: Arthrex Univers II Shoulder Prosthesis, Arthrex, Inc. (2007) Summary page 2.

## Most influential descendants
- K131633: Arthrex Univers Apex (2013), 4 descendants of its own
- K153115: Arthrex Univers Apex, Size 5 Stem (2015), 2 descendants of its own
- K171841: Arthrex Shoulder System (2018), 1 descendant of its own
- K230513: Arthrex Univers Apex OptiFit Humeral Stem (2023), 0 descendants of its own
- K230366: Arthrex Univers Revers Monoblock Stem Size 4/33 (2023), 0 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/K103466
Methodology: https://510kreport.com/methodology