# K252411: JARVIS Glenoid Reverse Shoulder Prosthesis

- Pathway: 510(k) (Special)
- Applicant: FH Industrie
- Decided: Aug 28, 2025 after 27 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: 17 generations back to K911686 (1991). 172 ancestors in all.
No later device cites it as a predicate yet.
1 of 173 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242253: JARVIS Glenoid Reverse Shoulder Prosthesis, FH Industrie (2024) Summary page 5.

## 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/K252411
Methodology: https://510kreport.com/methodology