# K062250: Delta Xtend Reverse Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Feb 2, 2007 after 184 days
- Product code: PHX (Shoulder Prosthesis, Reverse Configuration)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K911686 (1991). 12 ancestors in all.
250 later devices descend from it; 17 cite it directly.
0 of 263 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021478: Delta Shoulder, Depuy, Inc. (2003) Summary page 1.
- K062116: Delta Cta Reverse Shoulder System Humeral Heads, DePuy Orthopaedics, Inc. (2006). Cleared while this submission was under review Summary page 2.
- K992065: Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric Head, DePuy Orthopaedics, Inc. (1999) Summary page 1.
- K000575: Global Advantage Extended Humeral Head, DePuy Orthopaedics, Inc. (2000) Summary page 1.

## Most influential descendants
- K071379: Delta Xtend Reverse Shoulder Modular Stem (2007), 191 descendants of its own
- K082120: Aequalis Reversed Fracture Shoulder Prothesis (2008), 164 descendants of its own
- K073676: Depuy Delta Xtend Reverse Shoulder High Mobility Cup (2008), 161 descendants of its own
- K091751: Depuy Delta Xtend Reverse Shoulder XLK Cup (2009), 159 descendants of its own
- K100142: Aequalis Reversed Shoulder Prosthesis (2010), 147 descendants of its own

## Recalls of this device
- Jul 10, 2008 · Not classified · Z-0536-2009: Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable.
- Jul 10, 2008 · Not classified · Z-0537-2009: Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable.
- Jul 10, 2008 · Not classified · Z-0539-2009: Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable.
- Jul 10, 2008 · Not classified · Z-0538-2009: Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable.
- Jul 10, 2008 · Not classified · Z-0532-2009: Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable.
- Jul 10, 2008 · Not classified · Z-0533-2009: Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable.
- Jul 10, 2008 · Not classified · Z-0534-2009: Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable.
- Jul 10, 2008 · Not classified · Z-0535-2009: Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable.

## Indications for use
The Delta Xtend TM Reverse Shoulder prosthesis is intended for use as total shoulder or hemi-shoulder replacement. Delta XtendTM 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. In cases of bone defects in the proximal humerus, the monobloc implant should be used and then only in cases where the residual bone permits firm fixation of this implant. Delta XtendTm hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively. The metaglene component is HA coated and is intended for cementless use with the addition of screws for fixation. All other components are for cemented use only.

Source page: https://510kreport.com/device/K062250
Methodology: https://510kreport.com/methodology