# K201542: Arthrex Eclipse Shoulder Prosthesis System

- Pathway: 510(k) (Special)
- Applicant: Arthrex, Inc.
- Decided: Jul 8, 2020 after 29 days
- Product code: PKC (Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained)
- 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: 8 generations back to K911686 (1991). 25 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183194: Arthrex Eclipse Shoulder Prosthesis System, Arthrex, Inc. (2019) Summary page 4.

## Most influential descendants
- K203100: Arthrex Eclipse Titanium Humeral Head (2020), 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/K201542
Methodology: https://510kreport.com/methodology