# K183162: Affixus Hip Fracture Nail

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: Dec 14, 2018 after 29 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: 5 generations back to K970097 (1997). 12 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100238: HFN 125 Degree 9-13 MM, 180MM, HFN 130 Degree 9-13 MM, HFN RH 125 Degree 9-13MM, DePuy Orthopaedics, Inc. (2010) Summary page 4.

## Most influential descendants
- K233910: Vertex Hip Fracture Nailing System (2024), 0 descendants of its own
- K221489: Artemis Proximal Femoral Nail System (2022), 0 descendants of its own

## Indications for use
The Affixus Hip Fracture Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures, including non-union, malunion and tumor resections. The Long Nail system is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone (including prophylactic use) of the trochanteric and diaphyseal areas, impending pathological fractures, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal non-unions, malunions, revision procedures and tumor resections.

Source page: https://510kreport.com/device/K183162
Methodology: https://510kreport.com/methodology