# K183194: Arthrex Eclipse Shoulder Prosthesis System

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Jul 26, 2019 after 249 days
- Product code: QHQ (Total Shoulder Arthroplasty System)
- 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: 7 generations back to K911686 (1991). 24 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 33 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 4.
- K171858: Sidus Stem-Free Shoulder, Zimmer GmbH (2017) Summary page 4.
- K143552: Simpliciti Shoulder System, Tornier, Inc. (2015) Summary page 4.

## Most influential descendants
- K203108: Ignite Stemless Anatomic Shoulder System (2021), 3 descendants of its own
- K201542: Arthrex Eclipse Shoulder Prosthesis System (2020), 1 descendant of its own
- K243248: Inhance Intact™ (2024), 0 descendants of its own
- K230831: INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid (2023), 0 descendants of its own
- K221758: SMR Stemless Anatomic (2023), 0 descendants of its own

## Indications for use
The Arthrex Eclipse Shoulder Prosthesis is indicated for severely painful and/or disabled joint resulting from osteoarthritis or traumatic arthritis. The humeral component is fixated with a hollow screw and the glenoid components are intended for cemented fixation in the joint and must only be used with appropriate bone cement.

Source page: https://510kreport.com/device/K183194
Methodology: https://510kreport.com/methodology