# K183077: Delta Xtend Reverse Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Depuy (Ireland)
- Decided: May 17, 2019 after 193 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: 16 generations back to K911686 (1991). 139 ancestors in all.
No later device cites it as a predicate yet.
1 of 140 devices in its family (counting itself) has 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.
- K120174: Deput Delta Xtend Reverse Shoulder, Depuy France (2012) Summary page 4.
- K030941: Aequalis Reversed Shoulder Prosthesis, Tornier (2004) Summary page 4.
- K061439: Aequalis Reversed Prosthesis, Tornier (2006) Summary page 4.
- K081059: Aequalis Reversed Shoulder Prosthesis, Tornier (2008) Summary page 4.
- K140478: Aequalis Reversed Shoulder Prosthesis, Tornier S.A.S. (2014) Summary page 4.
- K151293: Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis, Tornier S.A.S. (2015) Summary page 4.

## Indications for use
The Delta Xtend Shoulder Prosthesis is indicated for use in treatment of a grossly deficient rotator cuff joint with: • severe arthropathy and/or; • a previously failed joint replacement and/or: • fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory 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. Delta Xtend hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively or for the 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 humeral epiphysis components are HA coated and intended for cementless use. All other metallic components are intended for cemented use only.

Source page: https://510kreport.com/device/K183077
Methodology: https://510kreport.com/methodology