# K000575: Global Advantage Extended Humeral Head

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Mar 10, 2000 after 17 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
No predicates in its family tree.
307 later devices descend from it; 9 cite it directly.
1 of 308 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K062116: Delta Cta Reverse Shoulder System Humeral Heads (2006), 295 descendants of its own
- K062250: Delta Xtend Reverse Shoulder System (2007), 250 descendants of its own
- K071379: Delta Xtend Reverse Shoulder Modular Stem (2007), 191 descendants of its own
- K063569: Equinoxe Reverse Shoulder System (2007), 190 descendants of its own
- K073688: Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw (2008), 177 descendants of its own

Source page: https://510kreport.com/device/K000575
Methodology: https://510kreport.com/methodology