# K081620: Modification to Depuy Delta Xtend Reverse Shoulder System

- Pathway: 510(k) (Special)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Jun 30, 2008 after 21 days
- Product code: KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented)
- 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: 8 generations back to K911686 (1991). 15 ancestors in all.
109 later devices descend from it; 1 cites it directly.
0 of 125 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062250: Delta Xtend Reverse Shoulder System, DePuy Orthopaedics, Inc. (2007) Summary page 4.
- K073676: Depuy Delta Xtend Reverse Shoulder High Mobility Cup, DePuy Orthopaedics, Inc. (2008) Summary page 4.

## Most influential descendants
- K110599: Aequalis Ascend Modular Reverse Shoulder System (2011), 108 descendants of its own
- K112615: Aequalis Ascend Modular Reverse Shoulder System (2011), 97 descendants of its own
- K122698: Aequalis Ascend Flex Shoulder System (2013), 96 descendants of its own
- K140082: Aequalis (TM) Ascent (TM) Flex Shoulder System (2014), 29 descendants of its own
- K132285: Aequalis Reversed Shoulder Prosthesis (2013), 26 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 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 Xtend hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively or for revision of a previously failed Delta Xtend Reverse Shoulder. The metaglene component is HA coated and is intended for cementless use with the addition of screws for fixation. The modular humeral stem and epiphysis components are HA coated and intended for cementless use. All other components are for cemented use only.

Source page: https://510kreport.com/device/K081620
Methodology: https://510kreport.com/methodology