# K974044: Global Total Shoulder Eccentric Humeral Head

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Jan 22, 1998 after 90 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.
440 later devices descend from it; 4 cite it directly.
1 of 441 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) DePuy Global Total Shoulder: named in the summary without a submission number
- (no number) DePuy Global Total Shoulder, Humeral Component, for Cemented or Uncemented Use: named in the summary without a submission number
- (no number) Global Total Shoulder (standard) Humeral Head: named in the summary without a submission number

## 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
The humeral components of the Global Total Shoulder are intended for cemented or cementless use as a total or herni-shoulder replacement which is indicated for: 1. A severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, or rheumatoid arthritis; 2. Fracture-dislocations of the proximal humerus where the articular surfaces are severely comminuted, separated from blood supply or where experience shows more conventional methods of treatment are unsatisfactory; 3. Other difficult clinical management problems where arthrodesis or resection are not acceptable (i.e., revision of a failed primary component). The glenoid components of the Global Total Shoulder are intended for cemented use only for the above indications. Hemi-shoulder replacement is also indicated for: 1. Ununited humeral head fractures of long duration; 2. Avascular necrosis of the humeral head.

Source page: https://510kreport.com/device/K974044
Methodology: https://510kreport.com/methodology