# K201379: Artemis Proximal Femoral Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Glw, Inc.
- Decided: Feb 19, 2021 after 269 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K013468 (2001). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043431: GAMMA3 Nail System, Howmedica Osteonics Corp. (2005) Summary page 4.

## Most influential descendants
- K221489: Artemis Proximal Femoral Nail System (2022), 0 descendants of its own

## Indications for use
The Artemis Proximal Femoral Nail System is indicated for fixation of stable and unstable intertrochanteric fractures, including but not limited to nonunion, malunion and tumor resections.

Source page: https://510kreport.com/device/K201379
Methodology: https://510kreport.com/methodology