# K130050: Titan Reverse Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Ascension Orthopedic
- Decided: Jun 18, 2013 after 160 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: 13 generations back to K911686 (1991). 104 ancestors in all.
9 later devices descend from it; 1 cites it directly.
1 of 114 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081016: Smith & Nephew, Inc., Promos Reverse Shoulder System, Smith & Nephew, Inc. (2008) Summary page 4.
- K113523: Limacorporate SMR Reverse Shoulder System, Lima Corporate S.P.A. (2011) Summary page 4.
- K110598: SMR Reverse Shoulder System, Lima Corporate S.P.A. (2011) Summary page 4.
- K120174: Deput Delta Xtend Reverse Shoulder, Depuy France (2012) Summary page 4.
- K062250: Delta Xtend Reverse Shoulder System, DePuy Orthopaedics, Inc. (2007) Summary page 4.
- K041066: Encore Reverse Shoulder Prosthesis, Encore Medical L.P. (2005) Summary page 4.
- K120739: Aequalis Adjustable Modular Reverse Shoulder System, Tornier, Inc. (2012) Summary page 4.

## Most influential descendants
- K161189: Integra TITAN Reverse Shoulder System (2016), 8 descendants of its own
- K190588: Integra TITAN Reverse Shoulder System (2019), 4 descendants of its own
- K173717: Integra TITAN Reverse Shoulder System (2018), 3 descendants of its own
- K181999: Integra TITAN Reverse Shoulder System (2018), 2 descendants of its own
- K242253: JARVIS Glenoid Reverse Shoulder Prosthesis (2024), 1 descendant of its own

## Indications for use
The Titan™ Reverse Shoulder System is indicated for use in a grossly deficient rotator cuff joint with severe arthropathy or a previous failed joint replacement with a grossly deficient rotator cuff joint. The patient’s joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device. The glenoid base plate is intended for cementless application with the addition of screws for fixation. The humeral stem is indicated for cemented or uncemented use and the humeral body component is intended for cementless use.

Source page: https://510kreport.com/device/K130050
Methodology: https://510kreport.com/methodology