# K211350: Bindex BI-2

- Pathway: 510(k) (Traditional)
- Applicant: Bone Index Finland, Ltd.
- Decided: Apr 29, 2022 after 361 days
- Product code: MUA (Bone Sonometer)
- Device class: 2
- Regulation: 21 CFR 892.1180
- 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 P990035 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161971: Bindex BI-2, Bone Index Finland, Ltd. (2017) Summary page 5.

## Indications for use
Bindex measures apparent cortical bone thickness at the proximal tibia and can be used in conjunction with other clinical risk factors or patient characteristics as an aid to the physician in the diagnosis of osteoporosis and other medical conditions leading to reduced bone strength and in the determination of fracture risk.

Source page: https://510kreport.com/device/K211350
Methodology: https://510kreport.com/methodology