# K112193: Arrow Reverse Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Fournitures Hospitalieres Industrie
- Decided: Jul 12, 2012 after 349 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: 10 generations back to K911686 (1991). 61 ancestors in all.
10 later devices descend from it; 8 cite it directly.
0 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053274: Anatomical Shoulder Inverse/Reverse, Zimmer GmbH (2006) Summary page 5.
- K073688: Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw, Exactech, Inc. (2008) Summary page 5.
- K063569: Equinoxe Reverse Shoulder System, Exactech, Inc. (2007) Summary page 5.
- K062250: Delta Xtend Reverse Shoulder System, DePuy Orthopaedics, Inc. (2007) Summary page 5.
- K093599: Arrow Anatomical Shoulder System, Fournitures Hospitalieres Industrie (2010) Summary page 5.

## Most influential descendants
- K142778: ARROW Reverse Shoulder long keel and short keel glenoid base (2015), 5 descendants of its own
- K162068: ARROW Anatomical Porous glenoid (2017), 4 descendants of its own
- K150568: ARROW Humeral stems size 6 and 16 (2015), 4 descendants of its own
- K171789: ARROW Reverse Porous Glenoid (2018), 3 descendants of its own
- K202024: ARROW Short Stem Humeral System (2021), 2 descendants of its own

## Indications for use
The ARROW® reverse shoulder prosthesis 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 of 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/K112193
Methodology: https://510kreport.com/methodology