# K203694: DELTA XTEND Reverse Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Ireland UC
- Decided: Jul 22, 2021 after 216 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). 76 ancestors in all.
No later device cites it as a predicate yet.
1 of 77 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120174: Deput Delta Xtend Reverse Shoulder, Depuy France (2012) Summary page 4.
- K192855: DELTA XTEND (TM) Reverse Shoulder System, Depuy (Ireland) (2020) Summary page 4.
- K161742: Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid, Tornier, Inc. (2016) Summary page 4.
- K183696: Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid, Tornier, Inc. (2019) Summary page 4.

## Indications for use
The DePuy Synthes DELTA XTEND™ Shoulder Prosthesis 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 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. Porous-coated epiphysis are indicated for use in total shoulder replacement only. The metaglene component is either HA coated or porous-coated and is intended for cementless use with the addition of screws for fixation. Central screws can only be used with the porous-coated metaglenes and are required to be used with porous-coating augmented metaglenes. The modular humeral stem is HA coated and is intended for cementless use. The HA coated humeral epiphysis is intended for cementless use. The porous-coated epiphysis is intended for cemented or cementless use. All other metallic components are intended for cemented use only.

Source page: https://510kreport.com/device/K203694
Methodology: https://510kreport.com/methodology