Cleared Traditional

K053218 - DBX DEMINERALIZED BONE MATRIX PUTTY/PAS...

K053218 is the FDA 510(k) clearance for DBX DEMINERALIZED BONE MATRIX PUTTY/PAS... by Musculoskeletal Transplant Foundation. It is a Class 2 Orthopedic device (product code MQV) cleared through the Traditional 510(k) pathway after a 406-day FDA review.

K053218 · Musculoskeletal Transplant Foundation · Orthopedic device
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Optimized for regulatory review, auditing and printing
Dec 2006
Decision
406d
Days
Class 2
Risk

K053218 is an FDA 510(k) clearance for the DBX DEMINERALIZED BONE MATRIX PUTTY/PASTE/MIX. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Musculoskeletal Transplant Foundation (Edison, US). The FDA issued a Cleared decision on December 28, 2006 after a review of 406 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Musculoskeletal Transplant Foundation devices

Submission Details

510(k) Number K053218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2005
Decision Date December 28, 2006
Days to Decision 406 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
284d slower than avg
Panel avg: 122d · This submission: 406d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 231
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K053218.
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