Cleared Traditional

K242149 - NovoSorb MTX

K242149 · Polynovo Biomaterials Pty, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2025
Decision
225d
Days
-
Risk

K242149 is an FDA 510(k) clearance for the NovoSorb® MTX. Classified as Absorbable Synthetic Wound Dressing (product code QSZ).

Submitted by Polynovo Biomaterials Pty, Ltd. (Melbourne, AU). The FDA issued a Cleared decision on March 5, 2025 after a review of 225 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Polynovo Biomaterials Pty, Ltd. devices

FDA 510(k) Submission Details - K242149

510(k) Number K242149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2024
Decision Date March 05, 2025
Days to Decision 225 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
110d slower than avg
Panel avg: 115d · This submission: 225d
Pathway characteristics
Predicate-based equivalence.

QSZ Device Classification - Class 0,

Product Code QSZ Absorbable Synthetic Wound Dressing
Device Class -
Definition Intended As A Physical Barrier To Cover The Wound And Provide A Moist Wound Environment. Intended To Be Left On Wounds After Topical Application.

Regulatory Peers - QSZ Absorbable Synthetic Wound Dressing

All 10
Devices cleared under the same product code (QSZ) and FDA review panel - the closest regulatory comparables to K242149.
Redermo Wound Matrix
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K251567 · Polynovo Biomaterials Pty, Ltd. · Jun 2025
SiOxD® Wound Matrix
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SiOxD Wound Matrix
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Restrata® MiniMatrix
K223725 · Acera Surgical, Inc. · May 2023
SiOxD Wound Matrix
K222189 · Sioxmed, LLC · Nov 2022