# K020345: Arthrex Univers Fracture Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Sep 6, 2002 after 217 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
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K181555: Arthrex Fracture Adapter Hemi Shoulder Prosthesis (2018), 1 descendant of its own
- K171841: Arthrex Shoulder System (2018), 1 descendant of its own
- K230366: Arthrex Univers Revers Monoblock Stem Size 4/33 (2023), 0 descendants of its own

## Indications for use
The Arthrex Shoulder Humeral Fracture Prosthesis is indicated for severe pain or significant disability resulting from degenerative, rheumatoid, or traumatic disease or injury of the glenohumeral joint. This includes traumatic or pathological conditions of the shoulder resulting in fracture of the glenohumeral joint, including impression fradures, comminuted fracture, humeral head fracture, displaced 3-or4-fragment proximal head fractures, avascular necrosis of the humeral head, and fractures of the anatomical neck. The Arthrex Shoulder Humeral Fracture Prosthesis is designed for cemented or non-cemented use. This device may be used for hemi or total shoulder repair, utilizing the appropriate Arthrex Univers Glenoid component, which is to be cemented in place.

Source page: https://510kreport.com/device/K020345
Methodology: https://510kreport.com/methodology