# K133462: Duocentric Reversed Shoulder Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Aston Medical
- Decided: Feb 7, 2014 after 87 days
- Product code: KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented)
- 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: 12 generations back to K911686 (1991). 43 ancestors in all.
No later device cites it as a predicate yet.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103251: Duocentric Reversed, Aston Medical (2011) Summary page 4.
- K091751: Depuy Delta Xtend Reverse Shoulder XLK Cup, DePuy Orthopaedics, Inc. (2009) Summary page 4.

## Indications for use
The Duocentric® Reversed shoulder prosthesis is indicated for use in case of gross rotator cuff deficiency including when it is associated with osteoarthritis, revision of previous arthroplasty or complex fracture of the humerus (3 fragments or more) in an older population (e.g. 65 years of age or older). 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. The humeral stem is intended for use with cement when polished or without cement when coated with Hydroxyapatite. All other components are intended for cementless use only. The glenoid baseplate is intended for cementless application with the addition of three screws for fixation. It is coated with a double layer of pure Titanium and Hydroxyapatite on its posterior side. The additional component bail out head is intended when, during primary surgery for the Duocentric® Reversed shoulder prosthesis 1) the glenoid bone stock appears to be insufficient to bear the implant of the glenoid components, or 2) the glenoid bone fractures intra-operatively.

Source page: https://510kreport.com/device/K133462
Methodology: https://510kreport.com/methodology