# K201391: Easytech® Anatomical Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Fx Shoulder USA, Inc.
- Decided: Feb 16, 2021 after 265 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.
No later device cites it as a predicate yet.
0 of 26 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.

## Indications for use
The Easytech® Anatomical Shoulder System is indicated for use in total shoulder replacement to treat a severely painful and/or disabled joint resulting from osteoarthritis. The humeral stemless of the Easytech® Anatomical Shoulder is intended for cementless use only. The glenoid components of the Easytech® Anatomical Shoulder System are intended for cemented use only. The patient’s joint must be anatomically and structurally suited to receive the selected implants and a functional rotator cuff is necessary to use the device.

Source page: https://510kreport.com/device/K201391
Methodology: https://510kreport.com/methodology