# K212683: GLOBAL ICON Stemless Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Depuy (Ireland)
- Decided: Jan 19, 2022 after 148 days
- Product code: PKC (Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained)
- 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: 7 generations back to K911686 (1991). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171858: Sidus Stem-Free Shoulder, Zimmer GmbH (2017) Summary page 5.
- K143552: Simpliciti Shoulder System, Tornier, Inc. (2015) Summary page 5.
- K011047: Global Advantage Humeral Stem with Porocoat, DePuy Orthopaedics, Inc. (2001) Summary page 5.
- K992065: Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric Head, DePuy Orthopaedics, Inc. (1999) Summary page 5.
- K984541: Global FX Humeral Stem, Global Advantage Humeral Head, DePuy Orthopaedics, Inc. (1999) Summary page 5.

## Indications for use
The Stemless Shoulder System is comprised of modular humeral fixation components and humeral heads to be used in total shoulder arthroplasty. The Stemless Shoulder System is indicated for a severely painful and/or disabled joint resulting from osteoarthritis or traumatic arthritis. The Stemless humeral components are intended for press-fit fixation without the use of bone cement. The glenoid components are intended only for use with bone cement.

Source page: https://510kreport.com/device/K212683
Methodology: https://510kreport.com/methodology