# K082715: Depuy Global AP Cta Humeral Head

- Pathway: 510(k) (Special)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Dec 18, 2008 after 92 days
- Product code: HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3690
- 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 K000575 (2000). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000575: Global Advantage Extended Humeral Head, DePuy Orthopaedics, Inc. (2000) Summary page 1.

## Most influential descendants
- K203230: Global Shoulder and Delta CTA systems (2021), 0 descendants of its own
- K110706: Exactech Equinoxe Cuff Tear Arthroplasty (Cta) Head (2011), 0 descendants of its own

## Indications for use
The Global AP CTA Humeral Head, used with a Global AP Humeral Stem, is indicated for use in hemi-shoulder replacement. 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. 3. Rotator cuff tear arthropathy. 4. Deformity and/or limited motion. Un-coated Global AP Humeral Stems are indicated for cemented use only. Global AP Humeral Stems with Porocoat® are indicated for cemented or cementless use.

Source page: https://510kreport.com/device/K082715
Methodology: https://510kreport.com/methodology