# K052472: Depuy Global Shoulder Crosslink Glenoid

- Pathway: 510(k) (Special)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Oct 6, 2005 after 28 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 K943462 (1994). 8 ancestors in all.
158 later devices descend from it; 7 cite it directly.
0 of 167 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981487: Depuy Global Shoulder Glenoid, DePuy Orthopaedics, Inc. (1998). Our reading of the summary gave K981497, FDA’s number for Steritec Disposable Biological Test Pack-EO Gas (Steritec Products Mfg Co, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “DePuy Global Shoulder Glenoid”. Summary page 1.
- K914000: Global (TM) Total Shoulder W/Dupont Enhanced Uhmwpe, Depuy, Inc. (1991) Summary page 2.
- K040166: Depuy Sigma XLK Tibial Inserts, DePuy Orthopaedics, Inc. (2004) Summary page 1.

## Most influential descendants
- K092122: Global Shoulder Steptech Anchor Peg Glenoid (2009), 75 descendants of its own
- K060694: Modular Hybrid Glenoid (2006), 57 descendants of its own
- K123122: Glenoid Intelligent Reusable Instrument System (Glenoid Iris) (2013), 56 descendants of its own
- K103835: Reunion Tsa System-Humeral Press-Fit & Cemented Stems Model 5569-YY-20XX (YY=P,C; XX=07-17,06L-12L) Reunion Tsa System N (2011), 43 descendants of its own
- K131129: Cas Psi Shoulder (2013), 39 descendants of its own

## Indications for use
The Glenoid is intended for use in total shoulder replacement surgery for patients suffering from: 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 communited, 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). Glenoid components are intended for cemented use only.

Source page: https://510kreport.com/device/K052472
Methodology: https://510kreport.com/methodology