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 Sep 5, 2025 as substantially equivalent to K220822 (3D-Shaper Medical S.L, 2022) and 1 other predicate after a 156-day review. Its family tree reaches back 8 generations to 1990.
- Decided
- Sep 5, 2025
- Review
- 156 days
- Class
- Class II
- Product code
- KGI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K890121 (1990). 36 ancestors in all, the oldest K883280 (1988). No later device cites it as a predicate yet.
- Root · 8 generations backK890121 Modified DPX Bone DensitometerLunar · 1990
- 7 generations backK961007 Expert Spine Morphotietry ReferenceLunar Corp. · 1996
- 6 generations backK011917 Advanced Hip Assessment SoftwareGe Lunar Corp. · 2001
- 5 generations backK061561 Hip Structural Analysis Software Option for the Hologic QDR X-Ray…Hologic, Inc. · 2006
- 4 generations backK082402 Osdx Hip BMD SystemImaging Therapeutics, Inc. · 2008
- 3 generations backK121716 TBS InsightMedimaps Group SA · 2012
- 2 generations backK152299 TBS iNsightMedimaps Group SA · 2016 · Recalled
- 1 generation backK191112 GEHC DXA Bone Densitometers with enCORE version 18GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2019 · Recalled
- This deviceK251022 3D-Shaper3D-Shaper Medical S.L · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K890121 | Modified DPX Bone Densitometer | Lunar | 1990 | — |
| −7 | K961007 | Expert Spine Morphotietry Reference | Lunar Corp. | 1996 | — |
| −6 | K011917 | Advanced Hip Assessment Software | Ge Lunar Corp. | 2001 | — |
| −5 | K061561 | Hip Structural Analysis Software Option for the Hologic QDR X-Ray Bone… | Hologic, Inc. | 2006 | — |
| −4 | K082402 | Osdx Hip BMD System | Imaging Therapeutics, Inc. | 2008 | — |
| −3 | K121716 | TBS Insight | Medimaps Group SA | 2012 | — |
| −2 | K152299 | TBS iNsight | Medimaps Group SA | 2016 | 2 |
| −1 | K191112 | GEHC DXA Bone Densitometers with enCORE version 18 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2019 | 1 |
| 0 (this device) | 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 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K220822 | 3D-ShaperSummary page 5…Class II REGULATION NUMBER 892.1170 REGULATION NAME Bone Densitometer PRODUCT CODE: KGI PREDICATE DEVICE(S): 3D-SHAPER (K220822) GEHC DXA Bone Densitometers with enCORE version 18 (K191112)… | 2022 |
| * | K191112 | GEHC DXA Bone Densitometers with enCORE version 18Summary page 5…eter PRODUCT CODE: KGI PREDICATE DEVICE(S): 3D-SHAPER (K220822) GEHC DXA Bone Densitometers with enCORE version 18 (K191112) 510(k) Summary 04-09-2025… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 35 years and passes through 8 companies; a new generation was cleared every 5.0 years on median.
- 4 of the 36 ancestors have a recall of any class.
How does its category compare?
All KGI devicesKGI Densitometer, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 the hip and allows the physician to estimate structural properties of the hip, such as cortical sBMD, trabecular vBMD and integral vBMD.
These values can then be compared to an adult reference population at the sole discretion of the physician. The results can assist the physician in the assessment of relative fracture risk.
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/K251022 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251022: 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/K251022
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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