# K210167: DELTA XTEND Reverse Shoulder System

- Pathway: 510(k) (Special)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Feb 19, 2021 after 29 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: 13 generations back to K911686 (1991). 68 ancestors in all.
No later device cites it as a predicate yet.
1 of 69 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 5.
- K071379: Delta Xtend Reverse Shoulder Modular Stem, DePuy Orthopaedics, Inc. (2007) Summary page 5.
- K120174: Deput Delta Xtend Reverse Shoulder, Depuy France (2012) Summary page 5.
- K192448: Delta Xtend Revers Shoulder System, Depuy (Ireland) (2019) Summary page 5.

## Indications for use
The DePuy DELTA XTEND™ Reverse Shoulder System is indicated for use in treatment of a grossly deficient rotator cuff joint with: -severe arthropathy and/or; -a previous 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 alternate 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™ Reverse Shoulder System 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 System. The metaglene component is HA coated and is intended for cementless use with the addition of screws for fixation. All other metallic components are intended for cemented use only.

Source page: https://510kreport.com/device/K210167
Methodology: https://510kreport.com/methodology