# K242253: JARVIS Glenoid Reverse Shoulder Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: FH Industrie
- Decided: Nov 25, 2024 after 117 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: 16 generations back to K911686 (1991). 171 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 173 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171789: ARROW Reverse Porous Glenoid, Fournitures Hospitalieres Industrie (2018) Summary page 5.
- K112193: Arrow Reverse Shoulder System, Fournitures Hospitalieres Industrie (2012) Summary page 5.
- K190588: Integra TITAN Reverse Shoulder System, Integra LifeSciences Corporation (2019) Summary page 5.
- K193373: Comprehensive® Reverse Shoulder, Biomet, Inc. (2020) Summary page 5.
- K162455: Humelock Reversed Shoulder, Fx Solutions (2017) Summary page 5.
- K161742: Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid, Tornier, Inc. (2016) Summary page 5.

## Most influential descendants
- K252411: JARVIS Glenoid Reverse Shoulder Prosthesis (2025), 0 descendants of its own

## Indications for use
REVERSE PROSTHESIS The Jarvis Glenoid Reverse Shoulder Prosthesis is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The glenoid baseplate is intended for cementless application with the addition of screws for fixation.

Source page: https://510kreport.com/device/K242253
Methodology: https://510kreport.com/methodology