# K253345: JARVIS Diaphyseal Stem Standard

- Pathway: 510(k) (Special)
- Applicant: FH Industrie
- Decided: Oct 29, 2025 after 29 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: 18 generations back to K911686 (1991). 164 ancestors in all.
1 later device descends from it; 1 cites it directly.
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 5.
- K093599: Arrow Anatomical Shoulder System, Fournitures Hospitalieres Industrie (2010). Our reading of the summary gave K093591, FDA’s number for Stimpod Model NMS-400 Nerve Stimulator (Xavant Technology (Pty), Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “FH Industrie ARROW Humeral Stem”.
- K112193: Arrow Reverse Shoulder System, Fournitures Hospitalieres Industrie (2012) Summary page 5.
- K150568: ARROW Humeral stems size 6 and 16, Fournitures Hospitalieres Industrie (2015) Summary page 5.

## Most influential descendants
- K254003: JARVIS Metaphyseal Stem (2026), 0 descendants of its own

## 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. For all types of prosthesis, the glenoid baseplate (porous) is intended for cementless use with the addition of bone screws for fixation, the humeral short stem (metaphyseal stem and diaphyseal stem) is intended for cementless use. At least 2/3 of the metaphyseal component must be implanted in the proximal humeral bone to allow for adequate humeral component fixation.

Source page: https://510kreport.com/device/K253345
Methodology: https://510kreport.com/methodology