Cleared Traditional

K241555 - Moldable Bone Void Filler and Moldable ...

K241555 is an FDA 510(k) clearance for Moldable Bone Void Filler and Moldable ..., manufactured by Rti Surgical, Inc.. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K241555 · Rti Surgical, Inc. · Orthopedic device
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Feb 2025
Decision
266d
Days
Class 2
Risk

K241555 is an FDA 510(k) clearance for the Moldable Bone Void Filler and Moldable Bone Void Filler + CCC. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Rti Surgical, Inc. (Alachua, US). The FDA issued a Cleared decision on February 21, 2025 after a review of 266 days - an extended review cycle.

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 Rti Surgical, Inc. devices

FDA 510(k) Submission Details - K241555

510(k) Number K241555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2024
Decision Date February 21, 2025
Days to Decision 266 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
144d slower than avg
Panel avg: 122d · This submission: 266d
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 Peers - MQV Filler, Bone Void, Calcium Compound

All 290
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