Cleared Traditional

K251408 - OsteoSight™ Hip (v1) (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K251408 · Naitive Technologies, Ltd. · Radiology device
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Sep 2025
Decision
119d
Days
Class 2
Risk

K251408 is an FDA 510(k) clearance for the OsteoSight™ Hip (v1). Classified as Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density (product code SAO), Class II - Special Controls.

Submitted by Naitive Technologies, Ltd. (Cambridge, GB). The FDA issued a Cleared decision on September 2, 2025 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1171 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Naitive Technologies, Ltd. devices

Submission Details

510(k) Number K251408 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2025
Decision Date September 02, 2025
Days to Decision 119 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 107d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code SAO Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1171
Definition This Device Is Software Which Opportunistically Assesses Radiological Images To Estimate Bone Mineral Density (bmd) Intended To Assist In A Healthcare Professional's Decision To Evaluate Patients For Possible Low Bmd Within A Bone Health Screening Program. The Software Employs An Algorithm That Estimates Bmd Using Eligible Radiological Image Data Obtained For Other Clinical Purposes.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - SAO Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density

Devices cleared under the same product code (SAO) and FDA review panel - the closest regulatory comparables to K251408.
Rho
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