# K103251: Duocentric Reversed

- Pathway: 510(k) (Traditional)
- Applicant: Aston Medical
- Decided: Oct 28, 2011 after 359 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: 11 generations back to K911686 (1991). 42 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091751: Depuy Delta Xtend Reverse Shoulder XLK Cup, DePuy Orthopaedics, Inc. (2009) Summary page 4.
- K021478: Delta Shoulder, Depuy, Inc. (2003) Summary page 4.
- K100142: Aequalis Reversed Shoulder Prosthesis, Tornier (2010) Summary page 4.
- K053274: Anatomical Shoulder Inverse/Reverse, Zimmer GmbH (2006). Our OCR of the scanned summary read K083274, FDA’s number for Worldwide Medical Technologies Anchor Marker, Marker… (Biocompatibles, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Zimmer Anatomical Shoulder Inverse/Reverse”. Summary page 6.

## Most influential descendants
- K142778: ARROW Reverse Shoulder long keel and short keel glenoid base (2015), 5 descendants of its own
- K162068: ARROW Anatomical Porous glenoid (2017), 4 descendants of its own
- K171789: ARROW Reverse Porous Glenoid (2018), 3 descendants of its own
- K242253: JARVIS Glenoid Reverse Shoulder Prosthesis (2024), 1 descendant of its own
- K252411: JARVIS Glenoid Reverse Shoulder Prosthesis (2025), 0 descendants of its own

## Indications for use
Implantation of a joint prosthesis is to be considered only when all other surgical options have been carefully examined and found less appropriate. 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 gienoid baseplate is intended for éementless application with the addition of three screws for fixation. It is coated with a double layer of pure Titanium and Hydroxyapafite on its posterior side.

Source page: https://510kreport.com/device/K103251
Methodology: https://510kreport.com/methodology