# K984541: Global FX Humeral Stem, Global Advantage Humeral Head

- Pathway: 510(k) (Special)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Jan 14, 1999 after 24 days
- Product code: KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K911686 (1991). 2 ancestors in all.
425 later devices descend from it; 10 cite it directly.
1 of 428 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911686: Global Total Shoulder, Uncement Humeral Hemi-Shoul, Depuy, Inc. (1991) Summary page 1.
- K914695: Global Total Shoulder, Depuy, Inc. (1992) Summary page 1.

## Most influential descendants
- K992065: Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric Head (1999), 405 descendants of its own
- K021478: Delta Shoulder (2003), 338 descendants of its own
- K062116: Delta Cta Reverse Shoulder System Humeral Heads (2006), 295 descendants of its own
- K030941: Aequalis Reversed Shoulder Prosthesis (2004), 280 descendants of its own
- K041873: Aequalis Reversed Shoulder Prosthesis (2004), 277 descendants of its own

## Indications for use
Total or hemi-shoulder replacement is indicated for: 1. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis; 2. Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon’s experience indicates that alternative methods of treatment are unsatisfactory; 3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g., revision of a failed primary component). Hemi-shoulder replacement is also indicated for: 1. Ununited humeral head fractures; 2. Avascular necrosis of the humeral head. Only the titanium alloy humeral stem components and the cobalt-chrome alloy humeral stem components, which are marketed under the Global Shoulder name, are intended for press-fit or cemented fixation. The glenoid components are for cemented use only. CAUTION: The cobalt-chrome alloy humeral components, which are marketed under the HRP Shoulder name and all glenoid components are for CEMENTED USE ONLY.

Source page: https://510kreport.com/device/K984541
Methodology: https://510kreport.com/methodology