# K011917: Advanced Hip Assessment Software

- Pathway: 510(k) (Traditional)
- Applicant: Ge Lunar Corp.
- Decided: Aug 3, 2001 after 44 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 K890121 (1990). 3 ancestors in all.
16 later devices descend from it; 5 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950611: Expert Morphomerty Softward, Lunar Corp. (1995) Summary page 1.
- K961007: Expert Spine Morphotietry Reference, Lunar Corp. (1996) Summary page 1.

## Most influential descendants
- K061561: Hip Structural Analysis Software Option for the Hologic QDR X-Ray Bone Densitometers (2006), 13 descendants of its own
- K072664: GE Lunar Femur Strength Software (2008), 7 descendants of its own
- K082402: Osdx Hip BMD System (2008), 6 descendants of its own
- K121716: TBS Insight (2012), 5 descendants of its own
- K161682: GE Lunar DXA Bone Densitometers with enCORE version 17 (2016), 4 descendants of its own

## Indications for use
Hip Morphometry Software option is used on a typical dual-energy x-ray absorptiometry (DEXA) image of a femur from a Prodigy bone densitometer. This software provides a measurement of the hip axis length (HAL) and a mean value of HAL for Caucasian females. The use of the Prodigy bone densitometer is restricted to prescription use only. The operator’s manual for these products contains the following statement: “United States Federal Law restricts this device to the sale, distribution, and use by or on the order of a physician.”

Source page: https://510kreport.com/device/K011917
Methodology: https://510kreport.com/methodology