# K162068: ARROW Anatomical Porous glenoid

- Pathway: 510(k) (Traditional)
- Applicant: Fournitures Hospitalieres Industrie
- Decided: Apr 10, 2017 after 258 days
- Product code: MBF (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3670
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K911686 (1991). 81 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093599: Arrow Anatomical Shoulder System, Fournitures Hospitalieres Industrie (2010) Summary page 5.
- K112193: Arrow Reverse Shoulder System, Fournitures Hospitalieres Industrie (2012) Summary page 5.
- K142778: ARROW Reverse Shoulder long keel and short keel glenoid base, Fournitures Hospitalieres Industrie (2015) Summary page 5.
- K030710: Bio-Modular Shoulder System, Biomet, Inc. (2003) Summary page 5.

## Most influential descendants
- K171789: ARROW Reverse Porous Glenoid (2018), 3 descendants of its own
- K242253: JARVIS Glenoid Reverse Shoulder Prosthesis (2024), 1 descendant of its own
- K252411: JARVIS Glenoid Reverse Shoulder Prosthesis (2025), 0 descendants of its own
- K232226: ARROW Off-Centred Humeral Insert (2023), 0 descendants of its own

## Indications for use
THE ARROW ANATOMICAL POROUS GLENOID, DEPENDING ON THE COMPONENTS USED, IS DESIGNED FOR: - CENTRED GLENOHUMERAL OSTEOARTHRITIS - RHEUMATOID POLYARTHRITIS - POST-TRAUMATIC SEQUELA WITH GLENOID INJURY - FRACTURES OF THE PROXIMAL HUMERUS 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 THE POROUS GLENOID BASE IS INTENDED FOR CEMENTLESS APPLICATION WITH THE ADDITION OF BONE SCREWS FOR FIXATION

Source page: https://510kreport.com/device/K162068
Methodology: https://510kreport.com/methodology