# K021478: Delta Shoulder

- Pathway: 510(k) (Traditional)
- Applicant: Depuy, Inc.
- Decided: Nov 18, 2003 after 559 days
- Product code: PHX (Shoulder Prosthesis, Reverse Configuration)
- 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 K911686 (1991). 9 ancestors in all.
338 later devices descend from it; 19 cite it directly.
1 of 348 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992119: Bio-Modular Shoulder System, Biomet, Inc. (1999) Summary page 1.
- K991585: Bipolar Shoulder Prosthesis, Biomet, Inc. (1999)
- K992065: Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric Head, DePuy Orthopaedics, Inc. (1999) Summary page 1.

## Most influential descendants
- K062116: Delta Cta Reverse Shoulder System Humeral Heads (2006), 295 descendants of its own
- K030941: Aequalis Reversed Shoulder Prosthesis (2004), 280 descendants of its own
- K041873: Aequalis Reversed Shoulder Prosthesis (2004), 277 descendants of its own
- K062250: Delta Xtend Reverse Shoulder System (2007), 250 descendants of its own
- K050316: Aequalis Reversed Shoulder Prosthesis (2005), 248 descendants of its own

## Indications for use
A Delta Total shoulder prosthesis is indicated for use in: Grossly rotator cuff deficient joint with severe arthropathy or a previous failed joint replacement with a grossly rotator cuff deficient joint. The patient’s joint must be anatomically and structurally suited to receive the selected implant(s), and a functional Deltoid muscle is necessary to use the device. The metaglene component is HA coated and is intended for cementless application with the addition of screws for fixation. All other components are intended for cemented use only.

Source page: https://510kreport.com/device/K021478
Methodology: https://510kreport.com/methodology