# K013923: Titanium Retrograde Femoral Nail - 13 MM Diameter

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Orthopedics, Inc.
- Decided: Feb 25, 2002 after 90 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: 1 generation back to K982953 (1998). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982953: Titanium Intramedullary Nails-Various Styles, Biomet, Inc. (1998) Summary page 1.

## Most influential descendants
- K021782: BNF (2002), 0 descendants of its own

## Indications for use
Femoral nails are to be used for treatment of fractures of the femur including: non-comminuted and comminuted mid-shaft fracture, subtrochanteric fracture, distal third fracture, combination fractures of the head and femoral neck, intertrochanteric fracture, combination intertrochanteric and subtrochanteric fractures. Other indications include: osteotomy and reconstructive procedures following tumor resection, and revision procedures where other treatments or devices have failed.

Source page: https://510kreport.com/device/K013923
Methodology: https://510kreport.com/methodology