# K220822: 3D-Shaper

- Pathway: 510(k) (Traditional)
- Applicant: 3D-Shaper Medical S.L
- Decided: Dec 9, 2022 after 263 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: 4 generations back to K890121 (1990). 17 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061561: Hip Structural Analysis Software Option for the Hologic QDR X-Ray Bone Densitometers, Hologic, Inc. (2006) Summary page 4.

## Most influential descendants
- K251022: 3D-Shaper (2025), 0 descendants of its own

## 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 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.

Source page: https://510kreport.com/device/K220822
Methodology: https://510kreport.com/methodology