# K142778: ARROW Reverse Shoulder long keel and short keel glenoid base

- Pathway: 510(k) (Traditional)
- Applicant: Fournitures Hospitalieres Industrie
- Decided: Mar 20, 2015 after 175 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: 12 generations back to K911686 (1991). 75 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 81 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112193: Arrow Reverse Shoulder System, Fournitures Hospitalieres Industrie (2012) Summary page 3.
- K103251: Duocentric Reversed, Aston Medical (2011) Summary page 4.

## Most influential descendants
- K162068: ARROW Anatomical Porous glenoid (2017), 4 descendants of its own
- K171789: ARROW Reverse Porous Glenoid (2018), 3 descendants of its own
- K242253: JARVIS Glenoid Reverse Shoulder Prosthesis (2024), 1 descendant of its own
- K252411: JARVIS Glenoid Reverse Shoulder Prosthesis (2025), 0 descendants of its own
- K232226: ARROW Off-Centred Humeral Insert (2023), 0 descendants of its own

## Indications for use
The ARROW® Reverse Shoulder long keel and short keel glenoid base is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a previously failed shoulder joint replacement with a grossly deficient rotator cuff. A functional deltoid muscle and adequate glenoid bone stock are necessary to use this device. The humeral stem is intended for cemented or cementless application while the metal-back glenoid baseplate is intended for cementless application with the addition of bone screws for fixation.

Source page: https://510kreport.com/device/K142778
Methodology: https://510kreport.com/methodology