Active Life Scientific

Company overview

Active Life Scientific is a Santa Barbara, California medical device manufacturer presenting its clinical offering under the BoneScore brand. Its official history dates its UC Santa Barbara spin-out to 2007. Co-founder Alexander Proctor is identified as Founder and CEO in the company’s current product-clearance announcement.

OsteoProbe is a handheld measurement device used on the tibia of adults after local anesthesia. It applies controlled microindentation and reports a Bone Material Strength Index (BMSi), branded commercially as BoneScore. This measures a tissue property distinct from bone mineral density measured by DXA.

The device received FDA De Novo classification in 2021 and subsequent 510(k) clearances, including K250216 in September 2025. Its cleared labeling specifically excludes diagnosing disease, predicting fracture risk or treating a clinical condition. The company designs and manufactures its devices in Santa Barbara and has received NIH-backed research funding.

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Products & regulatory status How does MedTechIndex get this information?

Summary

FDA granted De Novo classification DEN210013 on August 19, 2021, establishing the Class II bone indentation device category. Later 510(k) clearances include K221195 and K250216; the De Novo decision is a distinct pathway and is not counted as a third 510(k). ^{[8][9][10][1]}

The K250216 labeling describes measurement of bone tissue resistance to microindentation on the tibia of adults, reported as BMSi. It states that laboratory correlations with bone strength and fracture toughness have unknown clinical significance and that the device is not intended to diagnose disease, predict fracture risk or treat any clinical condition. Those limits govern interpretation of the broader BoneScore marketing language. ^{[8][9][10][1]}

Regulatory snapshot How to read this snapshot

U.S. FDA

2+

510(k) clearances

1+

De Novo grants

—

PMA approvals

—

Recall events

Latest recorded source review: 2026-11-06.

Scope: selected product families.

Commercial portfolio snapshot

Documented commercial product families.

Bone microindentation measurement device

OsteoProbe / BoneScore ↗

Handheld device for measuring bone tissue resistance to microindentation at the tibia in adults, reported as BMSi. BoneScore is the commercial brand for the measurement. The device is not intended to diagnose disease, predict fracture risk or treat a clinical condition. ^{[2][5][8][9][10]}

FDA De Novo classified and 510(k) cleared · K250216