# K251408: OsteoSight™ Hip (v1)

- Pathway: 510(k) (Traditional)
- Applicant: Naitive Technologies, Ltd.
- Decided: Sep 2, 2025 after 119 days
- Product code: SAO (Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density)
- Device class: 2
- Regulation: 21 CFR 892.1171
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN230023 (2024). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN230023: Rho, 16 Bit, Inc. (2024) Summary page 5.

## Indications for use
OsteoSight™ is a software application intended for use opportunistically with standard anteroposterior (AP) radiographs of the hip or pelvis performed in patients aged 50 years and older. OsteoSight™ provides a notification in the form of a report to aid radiologists and/or physician interpreters in identifying patients with possible low bone mineral density (BMD) at the femoral neck to prompt a clinical assessment of bone health. OsteoSight™ should not be used to rule out low BMD. Radiologists and referring clinicians should follow recommended practices for screening and assessment, regardless of the absence of an OsteoSight™ report.

Source page: https://510kreport.com/device/K251408
Methodology: https://510kreport.com/methodology