# K181555: Arthrex Fracture Adapter Hemi Shoulder Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Dec 21, 2018 after 191 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: 13 generations back to K911686 (1991). 47 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020345: Arthrex Univers Fracture Prosthesis, Arthrex, Inc. (2002) Summary page 4.
- K071032: Arthrex Univers II Shoulder Prosthesis, Arthrex, Inc. (2007) Summary page 4.
- K130129: Univers Revers Shoulder Prosthesis System, Arthrex, Inc. (2013) Summary page 4.
- K142863: Univers Rivers Shoulder Prosthesis System, Arthrex, Inc. (2014) Summary page 4.

## Most influential descendants
- K230366: Arthrex Univers Revers Monoblock Stem Size 4/33 (2023), 0 descendants of its own

## Indications for use
The Arthrex Fracture Adapter Hemi Shoulder 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 fractures, comminuted fracture, humeral head fracture, displaced 3-or-4-fragment proximal head fractures, avascular necrosis of the humeral head, and fractures of the anatomical neck. The Arthrex Fracture Adapter Hemi Shoulder Prosthesis is for uncemented use. The 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/K181555
Methodology: https://510kreport.com/methodology