510(k) · Cleared
Cleared3D-Shaper
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3D-Shaper Medical S.L · KGI Densitometer, Bone
Cleared on Dec 9, 2022 as substantially equivalent to K061561 (Hologic, Inc., 2006) after a 263-day review. Its family tree reaches back 4 generations to 1990. 1 later device descends from it.
- Decided
- Dec 9, 2022
- Review
- 263 days
- Class
- Class II
- Product code
- KGI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K890121 (1990). 17 ancestors in all, the oldest K883280 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK890121 Modified DPX Bone DensitometerLunar · 1990
- 3 generations backK961007 Expert Spine Morphotietry ReferenceLunar Corp. · 1996
- 2 generations backK011917 Advanced Hip Assessment SoftwareGe Lunar Corp. · 2001
- 1 generation backK061561 Hip Structural Analysis Software Option for the Hologic QDR X-Ray…Hologic, Inc. · 2006
- This deviceK220822 3D-Shaper3D-Shaper Medical S.L · 2022
- Descendant · cites it directly · 0 of its ownK251022 3D-Shaper3D-Shaper Medical S.L · 2025
Most influential descendants
Showing 1 of 1 · See all- K2510223D-Shaper3D-Shaper Medical S.L · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K890121 | Modified DPX Bone Densitometer | Lunar | 1990 | — |
| −3 | K961007 | Expert Spine Morphotietry Reference | Lunar Corp. | 1996 | — |
| −2 | 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 | — |
| 0 (this device) | K220822 | 3D-Shaper | 3D-Shaper Medical S.L | 2022 | — |
| +1 | K251022 | 3D-Shaper | 3D-Shaper Medical S.L | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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? (1)
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 |
|---|---|---|---|
| * | K061561 | Hip Structural Analysis Software Option for the Hologic QDR X-Ray Bone DensitometersSummary page 4…KGI PREDICATE DEVICE(S): HIP STRUCTURAL ANALYSIS SOFTWARE OPTION FOR THE HOLOGIC QDR X-RAY BONE DENSITOMETERS (K061561) Section 5 – 510(k) Summary Doc Ref.: 05… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251022 | 3D-Shaper | 2025 | 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 32 years and passes through 5 companies; a new generation was cleared every 6.3 years on median.
- 1 of the 17 ancestors has a recall of any class.
- Of its descendants, K251022 (3D-Shaper Medical S.L, 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K061561.
How does its category compare?
All KGI devicesKGI Densitometer, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
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?
3D-SHAPER uses data from conventional Dual Energy X-Ray Absorptiometry (DXA) scans to measure the distribution of bone mineral mass at specific cross sections or regions of the hip and allows the physician to estimate structural properties of the hip, such as CSA, CSMI, Z, Buckling Ratio, cortical sBMD, trabecular vBMD and integral vBMD.
3D-SHAPER is indicated to be used by qualified medical professionals to assist healthcare professionals in the bone health evaluation & changes, and cannot fully substitute their clinical judgement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220822 · printed Nov 5, 2026
Cite this page
510(k) Report. “K220822: 3D-Shaper.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K220822
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026