# K093599: Arrow Anatomical Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Fournitures Hospitalieres Industrie
- Decided: Nov 24, 2010 after 369 days
- Product code: KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented)
- 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: 5 generations back to K911686 (1991). 29 ancestors in all.
11 later devices descend from it; 5 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984541: Global FX Humeral Stem, Global Advantage Humeral Head, DePuy Orthopaedics, Inc. (1999)
- K992065: Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric Head, DePuy Orthopaedics, Inc. (1999) Summary page 1.
- K042021: Exactech Equinoxe Shoulder System, Exactech, Inc. (2004) Summary page 2.
- K061454: Exactech Equinoxe Shoulder Stems, Exactech, Inc. (2006) Summary page 2.

## Most influential descendants
- K112193: Arrow Reverse Shoulder System (2012), 10 descendants of its own
- 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

## Indications for use
The ARROW anatomical shoulder system, depending on the components used, is 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 - Centered osteoarthritis with a glenoid cavity not allowing implantation of a glenoid implant. - Rheumatoid polyarthritis with thin rotator cuff. - Off-centered osteoarthritis with irreparable cuff, and with maintained active elevation of at least 1200. Total anatomical prosthesis (cemented glenoid implant with 4 pegs) - Centered gleniohumeral osteoarthritis with functional rotator cuff - Rheumatoid polyarthritis with functional rotator cuff - Fracture sequela, functional rotator cuff with glenoid injury.

Source page: https://510kreport.com/device/K093599
Methodology: https://510kreport.com/methodology