# K254154: FX V135 EASYTECH® Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: FX Shoulder Solutions, Inc.
- Decided: May 1, 2026 after 130 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: 16 generations back to K911686 (1991). 121 ancestors in all.
No later device cites it as a predicate yet.
1 of 122 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213117: FX V135 Shoulder Prosthesis, Fx Shoulder USA, Inc. (2022) Summary page 6.

## Indications for use
The FX V135 EASYTECH® Shoulder System is intended for use in shoulder replacement to treat a severely painful and/or disabled joint. In an anatomic shoulder configuration, the humeral stemless anchor base of FX V135 EASYTECH® Shoulder System is indicated for cementless use only in primary total shoulder replacement to treat: - A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis; In an anatomic shoulder configuration requiring a total, revision or hemi-shoulder, the humeral stemless anchor base with the addition of the Short humeral stem is indicated for cementless use only to treat: - Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a previously implanted primary component, a humeral plate or a humeral nail). The glenoid components of the FX V135 EASYTECH® Shoulder System in the anatomic construct are intended for cemented use only. The patient’s joint must be anatomically and structurally suited to receive the selected implants. In a reverse shoulder configuration, the FX V135 EASYTECH® Shoulder System is indicated for primary or revision total shoulder arthroplasty for the relief of pain and to improve function in patients with massive and non-repairable rotator cuff tear. The reverse FX V135 EASYTECH® Shoulder System requires the humeral stemless anchor base with the addition of the cementless humeral stem. In a reverse shoulder configuration, the glenoid components of the FX V135 EASYTECH® Shoulder System are intended for cemented use only. The glenoid baseplate component is intended for cementless use with the addition of screws for fixation. The patient’s joint must be anatomically and structurally suited to receive the selected implants, and a functional deltoid muscle is necessary to use the device.

Source page: https://510kreport.com/device/K254154
Methodology: https://510kreport.com/methodology