# K254003: JARVIS Metaphyseal Stem

- Pathway: 510(k) (Special)
- Applicant: FH Industrie
- Decided: Jan 9, 2026 after 25 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: 19 generations back to K911686 (1991). 165 ancestors in all.
No later device cites it as a predicate yet.
1 of 166 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202024: ARROW Short Stem Humeral System, FH Industrie (2021) Summary page 6.
- K253345: JARVIS Diaphyseal Stem Standard, FH Industrie (2025) Summary page 6.

## Indications for use
The prostheses from FH Industrie are designed for specific indications such as: Simple humeral prosthesis - Humeral head necrosis without injury to the glenoid cavity. - Extensive humeral head cartilage damage without injury to the glenoid cavity - Centred osteoarthritis with a glenoid cavity not allowing implantation of a glenoid implant. - Rheumatoid polyarthritis with thin rotator cuff. - Off-centred osteoarthritis with irreparable cuff, and with maintained active elevation of at least 120°. Total anatomical prosthesis (cemented glenoid implant with pegs) - Centred glenohumeral osteoarthritis with functional rotator cuff - Rheumatoid polyarthritis with functional rotator cuff - Post-traumatic sequela, functional rotator cuff with glenoid injury. TOTAL ANATOMICAL PROSTHESIS (POROUS GLENOID IMPLANT) - Centred glenohumeral osteoarthritis - Rheumatoid polyarthritis - Post-traumatic sequela with glenoid injury - Revision for glenoid loosening - Glenoid bone loss, where bone graft is needed A functional rotator cuff is necessary to use this device REVERSE PROSTHESIS (METAL-BACK OR POROUS GLENOID IMPLANT) The ARROW and JARVIS 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. A functional deltoid muscle and adequate glenoid bone stock are necessary to use this device. At least 2/3 of the metaphyseal component must be implanted in the proximal humeral bone to allow for adequate humeral component fixation. Metaphyseal stems and diaphyseal stems are intended for use without cement. The glenoid bases (metal-back or porous) are intended for cementless use with the addition of cortical and cancellous bone screws.

Source page: https://510kreport.com/device/K254003
Methodology: https://510kreport.com/methodology