# K071379: Delta Xtend Reverse Shoulder Modular Stem

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Sep 11, 2007 after 117 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: 6 generations back to K911686 (1991). 13 ancestors in all.
191 later devices descend from it; 10 cite it directly.
0 of 205 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 1.
- K021478: Delta Shoulder, Depuy, Inc. (2003) Summary page 1.
- K992065: Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric Head, DePuy Orthopaedics, Inc. (1999) Summary page 1.

## Most influential descendants
- 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
- K081620: Modification to Depuy Delta Xtend Reverse Shoulder System (2008), 109 descendants of its own

## Indications for use
Delta XtendTM Reverse Shoulder prosthesis is indicated for use in a 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. 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 finn fixation of this implant. Delta XtendTM 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 stein 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/K071379
Methodology: https://510kreport.com/methodology