# K060874: Depuy Global AP Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Jun 28, 2006 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
Longest line of descent: 3 generations back to K911686 (1991). 9 ancestors in all.
200 later devices descend from it; 7 cite it directly.
0 of 210 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992065: Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric Head, DePuy Orthopaedics, Inc. (1999) Summary page 2.
- K030259: Amatomical Shoulder with Removable Head, Centerplus Orthopedics, Inc. (2003) Summary page 2.
- K990137: Anatomica Humeral Stem/Head Components, Sulzer Orthopedics, Inc. (1999) Summary page 2.

## Most influential descendants
- K063081: Aequalis Shoulder System (2006), 162 descendants of its own
- K071147: Nexa Orthopedics Total Shoulder System (2007), 120 descendants of its own
- K102924: Aequalis Ascend Modular Anatomic Shoulder System (2011), 110 descendants of its own
- K110599: Aequalis Ascend Modular Reverse Shoulder System (2011), 108 descendants of its own
- K113413: Ascend Shoulder System (2012), 105 descendants of its own

## Indications for use
Total Shoulder 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). The humeral components of the Global APTM Shoulder are intended for cemented or cementless use as a total or hemi-shoulder replacement. Glenoid components of the Global APTM Shoulder are indicated only for use with bone cement for the above indications. Hemi-shoulder replacement is also indicated for: 1. Ununited humeral head fractures; 2. Avascular necrosis of the humeral head. 3. Deformity and/or limited motion.

Source page: https://510kreport.com/device/K060874
Methodology: https://510kreport.com/methodology