# K050315: Delta Humeral Cups

- Pathway: 510(k) (Special)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: May 16, 2005 after 96 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: 4 generations back to K911686 (1991). 10 ancestors in all.
196 later devices descend from it; 4 cite it directly.
1 of 207 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021478: Delta Shoulder, Depuy, Inc. (2003) Summary page 1.

## Most influential descendants
- K063569: Equinoxe Reverse Shoulder System (2007), 190 descendants of its own
- K073688: Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw (2008), 177 descendants of its own
- K072804: Comprehensive RS Shoulder System (2007), 175 descendants of its own
- K080642: Comprehensive Reverse Shoulder (2008), 172 descendants of its own
- K110599: Aequalis Ascend Modular Reverse Shoulder System (2011), 108 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/K050315
Methodology: https://510kreport.com/methodology