Cleared Traditional

K253524 - AdaptosFuse Bone Graft

K253524 is an FDA 510(k) clearance for AdaptosFuse Bone Graft, manufactured by Biomendex OY. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K253524 · Biomendex OY · Orthopedic device
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Optimized for regulatory review, auditing and printing
Feb 2026
Decision
96d
Days
Class 2
Risk

K253524 is an FDA 510(k) clearance for the Adaptos®Fuse Bone Graft. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Biomendex OY (Tampere, FI). The FDA issued a Cleared decision on February 17, 2026 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3045 - the FDA orthopedic device regulatory 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 Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Biomendex OY devices

FDA 510(k) Submission Details - K253524

510(k) Number K253524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2025
Decision Date February 17, 2026
Days to Decision 96 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 122d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQV Device Classification - Class 2, Special Controls

Product Code MQV Filler, Bone Void, Calcium Compound
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3045
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 Orthopedic devices follow this clearance model.

Regulatory Consultant

Bruder Consulting & Venture Group
Susan Drapeau

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MQV Filler, Bone Void, Calcium Compound

All 290
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K253524.
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K252085 · Wright Medical Technology, Inc. (Stryker Corporation) · Sep 2025