# K202024: ARROW Short Stem Humeral System

- Pathway: 510(k) (Traditional)
- Applicant: FH Industrie
- Decided: Nov 30, 2021 after 496 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). 163 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K112193: Arrow Reverse Shoulder System, Fournitures Hospitalieres Industrie (2012) Summary page 6.
- K093599: Arrow Anatomical Shoulder System, Fournitures Hospitalieres Industrie (2010) Summary page 6.
- K150568: ARROW Humeral stems size 6 and 16, Fournitures Hospitalieres Industrie (2015). Our reading of the summary gave K150569, FDA’s number for LaparoVue (Buffalo Filter, LLC). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “FH Industrie, Arrow Humeral Stem”.
- K162726: Exactech® Equinoxe® Preserve Stem, Exactech, Inc. (2017) Summary page 6.
- K190290: AltiVate Reverse Humeral Stem, 48mm, Encore Medical L.P. (2019) Summary page 6.
- K060692: Comprehensive Primary Shoulder Stems, Biomet Manufacturing Corp (2006) Summary page 6.
- K080642: Comprehensive Reverse Shoulder, Biomet, Inc. (2008) Summary page 6.
- K021478: Delta Shoulder, Depuy, Inc. (2003) Summary page 6.

## Most influential descendants
- K253345: JARVIS Diaphyseal Stem Standard (2025), 1 descendant of its own
- 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 4 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 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 (metal-back or 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/K202024
Methodology: https://510kreport.com/methodology