# K251022: 3D-Shaper

- Pathway: 510(k) (Traditional)
- Applicant: 3D-Shaper Medical S.L
- Decided: Sep 5, 2025 after 156 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: 8 generations back to K890121 (1990). 36 ancestors in all.
No later device cites it as a predicate yet.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220822: 3D-Shaper, 3D-Shaper Medical S.L (2022) Summary page 5.
- K191112: GEHC DXA Bone Densitometers with enCORE version 18, GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC (2019) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K251022
Methodology: https://510kreport.com/methodology