# K221489: Artemis Proximal Femoral Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Glw, Inc.
- Decided: Oct 27, 2022 after 157 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: 8 generations back to K792022 (1979). 63 ancestors in all.
No later device cites it as a predicate yet.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201379: Artemis Proximal Femoral Nail System, Glw, Inc. (2021) Summary page 4.
- K043431: GAMMA3 Nail System, Howmedica Osteonics Corp. (2005) Summary page 4.
- K213005: Apollo Ankle Fracture Plating System, Glw Medical, Inc. (2022) Summary page 4.
- K200291: CREED™ Cannulated Screws, Glw Medical, Inc. (2020) Summary page 4.
- K183162: Affixus Hip Fracture Nail, Biomet, Inc. (2018) Summary page 4.

## 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. Additionally, the long nail kit is indicated for the fixation of subtrochanteric fractures and shaft fracture extending distally to a point approximately 10 cm proximal to the intercondylar notch.

Source page: https://510kreport.com/device/K221489
Methodology: https://510kreport.com/methodology