# K062116: Delta Cta Reverse Shoulder System Humeral Heads

- Pathway: 510(k) (Special)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Aug 18, 2006 after 24 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). 11 ancestors in all.
295 later devices descend from it; 4 cite it directly.
1 of 307 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.
- K000575: Global Advantage Extended Humeral Head, DePuy Orthopaedics, Inc. (2000) Summary page 2.

## Most influential descendants
- K062250: Delta Xtend Reverse Shoulder System (2007), 250 descendants of its own
- K071379: Delta Xtend Reverse Shoulder Modular Stem (2007), 191 descendants of its own
- 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
- K080642: Comprehensive Reverse Shoulder (2008), 172 descendants of its own

## Indications for use
A Delta CTA Reverse Shoulder prosthesis is indicated for use in a grossly deficient rotator cuff joint with severe arthropathy or a previous failed joint replacement with a grossly deficient rotator cuff 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 fbr cemented use only.

Source page: https://510kreport.com/device/K062116
Methodology: https://510kreport.com/methodology