# K130129: Univers Revers Shoulder Prosthesis System

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: May 31, 2013 after 134 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: 11 generations back to K911686 (1991). 42 ancestors in all.
28 later devices descend from it; 6 cite it directly.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053274: Anatomical Shoulder Inverse/Reverse, Zimmer GmbH (2006) Summary page 4.
- K100142: Aequalis Reversed Shoulder Prosthesis, Tornier (2010) Summary page 4.

## Most influential descendants
- K142863: Univers Rivers Shoulder Prosthesis System (2014), 27 descendants of its own
- K173900: Arthrex Univers Revers Modular Glenoid System (2018), 17 descendants of its own
- K193372: Univers Revers Modular Glenoid System (Augemented baseplates) (2020), 13 descendants of its own
- K202611: Catalyst OrthoScience R1 Reverse Shoulder System (2021), 5 descendants of its own
- K231911: Glenoid Reconstruction System – Full Wedge Baseplate (2023), 4 descendants of its own

## Indications for use
The Univers Revers Shoulder Prosthesis is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy or a previous failed joint replacement with gross rotator cuff deficiency. 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 glenoid baseplate is CaP coated and is intended for cementless use with the addition of screws for fixation. The uncoated cup and stem are intended for cemented use, all other components are for cementless use only.

Source page: https://510kreport.com/device/K130129
Methodology: https://510kreport.com/methodology