# K130277: Single Energy (SE) Femur Exams

- Pathway: 510(k) (Traditional)
- Applicant: Hologic, Inc.
- Decided: May 31, 2013 after 116 days
- Product code: KGI (Densitometer, Bone)
- Device class: 2
- Regulation: 21 CFR 892.1170
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K945668 (1994). 4 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060111: Iva (Mxa II Software Option), Hologic, Inc. (2006) Summary page 2.

## Most influential descendants
- K161682: GE Lunar DXA Bone Densitometers with enCORE version 17 (2016), 4 descendants of its own
- K191112: GEHC DXA Bone Densitometers with enCORE version 18 (2019), 2 descendants of its own
- K252718: Lunar Astra (2026), 0 descendants of its own
- K251022: 3D-Shaper (2025), 0 descendants of its own
- K180782: Aria (2018), 0 descendants of its own

## Indications for use
Single Energy (SE) Femur Exams are used to visualize focal reaction or thickening along the lateral cortex of the femoral shaft which may be accompanied by a transverse radiolucent line. Clinical correlation is advised as these features may be consistent with atypical femur fractures, a complication associated with long term use of antiresorptive therapy.

Source page: https://510kreport.com/device/K130277
Methodology: https://510kreport.com/methodology