510(k) · Cleared
ClearedAdvanced Hip Assessment Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Lunar Corp. · KGI Densitometer, Bone
Cleared on Aug 3, 2001 as substantially equivalent to K950611 (Lunar Corp., 1995) and 1 other predicate after a 44-day review. Its family tree reaches back 2 generations to 1990. 16 later devices descend from it.
- Decided
- Aug 3, 2001
- Review
- 44 days
- Class
- Class II
- Product code
- KGI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K890121 (1990). 3 ancestors in all. 16 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK890121 Modified DPX Bone DensitometerLunar · 1990
- 1 generation backK961007 Expert Spine Morphotietry ReferenceLunar Corp. · 1996
- This deviceK011917 Advanced Hip Assessment SoftwareGe Lunar Corp. · 2001
- Descendant · cites it directly · 13 of its ownK061561 Hip Structural Analysis Software Option for the Hologic QDR X-Ray…Hologic, Inc. · 2006
- Descendant · cites it directly · 7 of its ownK072664 GE Lunar Femur Strength SoftwareGe Medical Systems Ultrasound and Primary Care Dia · 2008
- Descendant · 2 generations on · 6 of its ownK082402 Osdx Hip BMD SystemImaging Therapeutics, Inc. · 2008
- Descendant · 3 generations on · 5 of its ownK121716 TBS InsightMedimaps Group SA · 2012
- Descendant · cites it directly · 4 of its ownK161682 GE Lunar DXA Bone Densitometers with enCORE version 17GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2016 · Recalled
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K061561Hip Structural Analysis Software Option for the Hologic QDR X-Ray Bone DensitometersHologic, Inc. · 2006 · cites it directly13descendants
- K072664GE Lunar Femur Strength SoftwareGe Medical Systems Ultrasound and Primary Care Dia · 2008 · cites it directly7descendants
- K082402Osdx Hip BMD SystemImaging Therapeutics, Inc. · 2008 · 2 generations on6descendants
- K121716TBS InsightMedimaps Group SA · 2012 · 3 generations on5descendants
- K161682GE Lunar DXA Bone Densitometers with enCORE version 17GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2016 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K890121 | Modified DPX Bone Densitometer | Lunar | 1990 | — |
| −1 | K961007 | Expert Spine Morphotietry Reference | Lunar Corp. | 1996 | — |
| 0 (this device) | K011917 | Advanced Hip Assessment Software | Ge Lunar Corp. | 2001 | — |
| +1 | K061561 | Hip Structural Analysis Software Option for the Hologic QDR X-Ray Bone… | Hologic, Inc. | 2006 | — |
| +1 | K072664 | GE Lunar Femur Strength Software | Ge Medical Systems Ultrasound and Primary Care Dia | 2008 | — |
| +2 | K082402 | Osdx Hip BMD System | Imaging Therapeutics, Inc. | 2008 | — |
| +3 | K121716 | TBS Insight | Medimaps Group SA | 2012 | — |
| +1 | K161682 | GE Lunar DXA Bone Densitometers with enCORE version 17 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2016 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2012 | 2 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KGI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KGI device
- #1 K252718 Lunar Astrascore 13.3 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K950611 | Expert Morphomerty SoftwardSummary page 1…sment Software Option Common Name: Bone Densitometer Classification Name: Bone Densitometer 21CFR 892.1170 Predicate Devices: LUNAR EXPERT Morphometry Software 510(k) K950611 LUNAR EXPERT Spine Morphometry Reference Values 510(k) Number K961007 10.1 DESCRIPTION OF THE DEVICE: The Hip Morphometry Soft… | 1995 |
| * | K961007 | Expert Spine Morphotietry ReferenceSummary page 1…ame: Bone Densitometer 21CFR 892.1170 Predicate Devices: LUNAR EXPERT Morphometry Software 510(k) K950611 LUNAR EXPERT Spine Morphometry Reference Values 510(k) Number K961007 10.1 DESCRIPTION OF THE DEVICE: The Hip Morphometry Software, to be marketed as Advanced Hip Assessment Software, analyzes prev… | 1996 |
What descends from it? (16)
See all 165 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061561 | Hip Structural Analysis Software Option for the Hologic QDR X-Ray Bone Densitometers | 2006 | 13 |
| K072664 | GE Lunar Femur Strength Software | 2008 | 7 |
| K161682 | GE Lunar DXA Bone Densitometers with enCORE version 17 | 2016 | 4 |
| K052581 | Lunar Idxa | 2005 | 1 |
| K072439 | GE Lunar DPX & Prodigy Series Dexa Bone Densitometers with Mobile Kit | 2007 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 6.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K061561 (Hologic, Inc., 2006) has gone furthest, with 13 descendants of its own.
- 2 other devices also cite its predicate K950611.
How does its category compare?
All KGI devicesKGI Densitometer, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KGI
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KGI
156in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KGI
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KGI
8in 2025
MAUDE reports naming product code KGI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 5 | 173 | 6 | 2 |
| 2009 | 1 | — | 9 | 3 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 1 | 5 |
| 2012 | 5 | 142 | 0 | 1 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 2 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 1 | 1 |
| 2017 | 0 | — | 0 | 16 |
| 2018 | 1 | — | 0 | 6 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 3 | 156 | 0 | 8 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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.”
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K011917 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011917: Advanced Hip Assessment Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011917
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026