# K161189: Integra TITAN Reverse Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Integra LifeSciences Corporation
- Decided: Aug 25, 2016 after 120 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: 14 generations back to K911686 (1991). 105 ancestors in all.
8 later devices descend from it; 4 cite 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)
- K130050: Titan Reverse Shoulder System, Ascension Orthopedic (2013) Summary page 4.

## Most influential descendants
- 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
- K252411: JARVIS Glenoid Reverse Shoulder Prosthesis (2025), 0 descendants 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 previously failed joint replacement with a grossly deficient rotator cuff joint. The patient's joint must be anatomically and structurally suited to receive the selected mmplants and a functional deltoid muscle i1s necessary to use the device. The Titan Reverse Shoulder System is indicated for primary. fractures-including proximal humeral. or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. The glenoid base plate i1s 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/K161189
Methodology: https://510kreport.com/methodology