# K150568: ARROW Humeral stems size 6 and 16

- Pathway: 510(k) (Traditional)
- Applicant: Fournitures Hospitalieres Industrie
- Decided: Oct 29, 2015 after 237 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: 11 generations back to K911686 (1991). 62 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093599: Arrow Anatomical Shoulder System, Fournitures Hospitalieres Industrie (2010) Summary page 3.
- K112193: Arrow Reverse Shoulder System, Fournitures Hospitalieres Industrie (2012) Summary page 3.
- K042021: Exactech Equinoxe Shoulder System, Exactech, Inc. (2004) Summary page 5.
- K061454: Exactech Equinoxe Shoulder Stems, Exactech, Inc. (2006) Summary page 5.
- K063569: Equinoxe Reverse Shoulder System, Exactech, Inc. (2007) Summary page 5.
- K073688: Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw, Exactech, Inc. (2008) Summary page 5.

## Most influential descendants
- K202024: ARROW Short Stem Humeral System (2021), 2 descendants of its own
- K253345: JARVIS Diaphyseal Stem Standard (2025), 1 descendant of its own
- K254003: JARVIS Metaphyseal Stem (2026), 0 descendants of its own
- K232226: ARROW Off-Centred Humeral Insert (2023), 0 descendants of its own

## Indications for use
ARROW® Humeral stems size 6 and 16, depending on the components used, are designed for: SIMPLE HUMERAL PROSTHESIS: - Fracture dislocation or complex four part fracture of the proximal humerus - Humeral head necrosis without injury to the glenoid cavity. - Extensive humeral head cartilage damage without injury to the glenoid cavity - Centred osteoarthritis with a glenoid cavity not allowing implantation of a glenoid implant. - Rheumatoid polyarthritis with thin rotator cuff. - Off-centred osteoarthritis with irreparable cuff, and with maintained active elevation of at least 120°. TOTAL ANATOMICAL PROSTHESIS (CEMENTED GLENOID IMPLANT WITH 4 PEGS): - Centred glenohumeral osteoarthritis with functional rotator cuff - Rheumatoid polyarthritis with functional rotator cuff - Fracture sequela, functional rotator cuff with glenoid injury. REVERSE PROSTHESIS: 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 metal-back glenoid baseplate is intended for cementless application with the addition of bone screws for fixation.

Source page: https://510kreport.com/device/K150568
Methodology: https://510kreport.com/methodology