# K250216: OsteoProbe (OP-100)

- Pathway: 510(k) (Traditional)
- Applicant: Active Life Scientific, Inc.
- Decided: Sep 11, 2025 after 230 days
- Product code: QGQ (Bone Indentation Device)
- Device class: 2
- Regulation: 21 CFR 888.1600
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN210013 (2021). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221195: OsteoProbe, Active Life Scientific, Inc. (2022) Summary page 6.

## Indications for use
The OsteoProbe is a measurement tool intended to assess bone tissue resistance to microindentation on the tibia of adults, reported as the Bone Material Strength Index (BMSi). In laboratory studies, BMSi measurements have been shown to correlate with biomechanical properties of bone, including whole-bone strength and fracture toughness. The clinical significance of laboratory-based biomechanical studies is unknown. The device is not intended to diagnose disease, predict fracture risk, or treat any clinical condition. Prescription use only, by or on the order of a physician.

Source page: https://510kreport.com/device/K250216
Methodology: https://510kreport.com/methodology