# K011099: Global FX Porous-Coated Humeral Stem

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Jul 6, 2001 after 86 days
- Product code: MBF (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3670
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K911686 (1991). 4 ancestors in all.
75 later devices descend from it; 3 cite it directly.
0 of 80 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984541: Global FX Humeral Stem, Global Advantage Humeral Head, DePuy Orthopaedics, Inc. (1999) Summary page 1.
- K943300: Depuy Porous Coated Global Shoulder, Depuy, Inc. (1994) Summary page 1.

## Most influential descendants
- K042021: Exactech Equinoxe Shoulder System (2004), 71 descendants of its own
- K070565: Cofield Total Shoulder System (2007), 26 descendants of its own
- K093430: Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage, Glenoid Contd. (2010), 24 descendants of its own
- K103419: Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TM (2010), 22 descendants of its own
- K111379: Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large / Extra-Large, Left / Right (2011), 21 descendants of its own

## Indications for use
Total 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). 4. Rotator cuff tear arthropathy. Hemi-shoulder replacement is also indicated for: 1. Ununited humeral head fractures; 2. Awvascular necrosis of the humeral head. Porocoat® Porous-Coated Components Porocoat porous-coated humeral stem prostheses are indicated for cemented or cementless use with fixation provided by biological tissue in-growth into the porous coating. Cemented Components Humeral stem and Glenoid components labeled “For cemented use only” are indicated only for use with bone cement.

Source page: https://510kreport.com/device/K011099
Methodology: https://510kreport.com/methodology