# K063652: Global AP Porous Coated Humeral Stem

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Feb 1, 2007 after 55 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: 4 generations back to K911686 (1991). 11 ancestors in all.
18 later devices descend from it; 2 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060874: Depuy Global AP Shoulder System, DePuy Orthopaedics, Inc. (2006) Summary page 1.
- K011047: Global Advantage Humeral Stem with Porocoat, DePuy Orthopaedics, Inc. (2001). Our reading of the summary gave K001047, FDA’s number for Guthrie Latex Surgical Glove (Pre-Powdered) (Guthrie Medicare Products (Melaka) Sdn Bhd). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Global® Advantage Shoulder Humeral Stem with Porocoat®”.

## Most influential descendants
- K101996: Depuy Global Unite Shoulder System (2010), 16 descendants of its own
- K170748: GLOBAL UNITE Platform Shoulder System (2018), 10 descendants of its own
- K170910: Medacta Anatomic Shoulder Prosthesis (2017), 8 descendants of its own
- K191433: AGILON® XO Shoulder Replacement System (2020), 3 descendants of its own
- K192855: DELTA XTEND (TM) Reverse Shoulder System (2020), 3 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. Global APTM Porous Coated Humeral Stems are intended for cemented or cementless use, with fixation provided by biological tissue ingrowth into the porous coating. 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/K063652
Methodology: https://510kreport.com/methodology