# K981487: Depuy Global Shoulder Glenoid

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Jul 13, 1998 after 77 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.
335 later devices descend from it; 12 cite it directly.
1 of 336 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 System: named in the summary without a submission number
- (no number) Global Total Shoulder with DuPont Enhanced UHMWPe: named in the summary without a submission number

## Most influential descendants
- K030710: Bio-Modular Shoulder System (2003), 253 descendants of its own
- K043100: Bio-Modular Shoulder System with Hydroxyapatite (HA) Coated Glenoid Components (2005), 176 descendants of its own
- K072804: Comprehensive RS Shoulder System (2007), 175 descendants of its own
- K080642: Comprehensive Reverse Shoulder (2008), 172 descendants of its own
- K052472: Depuy Global Shoulder Crosslink Glenoid (2005), 158 descendants of its own

## Indications for use
The DePuy Global Shoulder Glenoid is intended for use as a cemented glenoid component in total shoulder arthroplasty completed using humeral components of the DePuy Global Total Shoulder System. The humeral components of the Global Total Shoulder System are intended for cemented or cementless use as a total or hemi-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 System 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/K981487
Methodology: https://510kreport.com/methodology