# DEN210013: OsteoProbe

- Pathway: De Novo (Direct)
- Applicant: Active Life Scientific, Inc.
- Decided: Aug 19, 2021 after 142 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K221195: OsteoProbe (2022), 1 descendant of its own
- K250216: OsteoProbe (OP-100) (2025), 0 descendants of its own

## Indications for use
The OsteoProbe is indicated for use as a measurement tool to measure bone tissue resistance to microindentation on the tibia in adults. The clinical significance of resistance to microindentation is unknown. The device is not intended to diagnose or treat any clinical condition.

Source page: https://510kreport.com/device/DEN210013
Methodology: https://510kreport.com/methodology