# K190588: Integra TITAN Reverse Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Integra LifeSciences Corporation
- Decided: Dec 2, 2019 after 270 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: 15 generations back to K911686 (1991). 106 ancestors in all.
4 later devices descend from it; 3 cite it directly.
1 of 111 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161189: Integra TITAN Reverse Shoulder System, Integra LifeSciences Corporation (2016) Summary page 4.

## Most influential descendants
- K242253: JARVIS Glenoid Reverse Shoulder Prosthesis (2024), 1 descendant of its own
- K252411: JARVIS Glenoid Reverse Shoulder Prosthesis (2025), 0 descendants of its own
- K213827: TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (HRA), Modular Radial Head System (MRH), Katalyst Bipolar Radial Head System (Katalyst) (2022), 0 descendants of its own
- K212992: LINK® Embrace Shoulder System - Reverse Configuration (2021), 0 descendants of its own

## Indications for use
The Integra 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 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 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/K190588
Methodology: https://510kreport.com/methodology