# K223801: FX V135(TM) Shoulder Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Fx Shoulder USA, Inc.
- Decided: Jun 5, 2023 after 168 days
- Product code: PHX (Shoulder Prosthesis, Reverse Configuration)
- 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.
2 later devices descend from it; 1 cites it directly.
1 of 124 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 4.

## Most influential descendants
- K250644: MSS - Monobloc stem (2026), 1 descendant of its own
- K261016: MSS - Humeral reverse liners extension (2026), 0 descendants of its own

## Indications for use
In an anatomic shoulder configuration, the FX V135™ Shoulder System is indicated for use in total and hemi-shoulder replacement to treat: - a severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis; - 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). In a reverse shoulder configuration, the FX V135™ Shoulder 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 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. The humeral stem of the FX V135™ Cementless Shoulder is intended for cementless use only, with optional cortical bone screws for the longer stems. The glenoid components of the FX V135™ Shoulder System are intended for cemented use only. The glenoid baseplate component is intended for cementless use with the addition of screws for fixation.

Source page: https://510kreport.com/device/K223801
Methodology: https://510kreport.com/methodology