# K232226: ARROW Off-Centred Humeral Insert

- Pathway: 510(k) (Special)
- Applicant: FH Industrie
- Decided: Aug 29, 2023 after 33 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). 118 ancestors in all.
No later device cites it as a predicate yet.
1 of 119 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112193: Arrow Reverse Shoulder System, Fournitures Hospitalieres Industrie (2012) Summary page 4.
- K150568: ARROW Humeral stems size 6 and 16, Fournitures Hospitalieres Industrie (2015) Summary page 4.
- K122698: Aequalis Ascend Flex Shoulder System, Tornier S.A.S. (2013) Summary page 5.
- K171789: ARROW Reverse Porous Glenoid, Fournitures Hospitalieres Industrie (2018) Summary page 5.
- K132285: Aequalis Reversed Shoulder Prosthesis, Tornier S.A.S. (2013) Summary page 5.

## Indications for use
The ARROW Off-Centred Humeral Insert is designed for the following indications: REVERSE PROSTHESIS (POROUS GLENOID IMPLANT) 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 or cementless application while the porous glenoid baseplate is intended for cementless application with the addition of bone screws for fixation.

Source page: https://510kreport.com/device/K232226
Methodology: https://510kreport.com/methodology