Cleared Special

K221686 - NovoSorb Matrix (FDA 510(k) Clearance)

K221686 · Polynovo Biomaterials Pty, Ltd. · General & Plastic Surgery device
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Sep 2022
Decision
97d
Days
-
Risk

K221686 is an FDA 510(k) clearance for the NovoSorb Matrix. Classified as Absorbable Synthetic Wound Dressing (product code QSZ).

Submitted by Polynovo Biomaterials Pty, Ltd. (Port Melbourne, AU). The FDA issued a Cleared decision on September 15, 2022 after a review of 97 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Polynovo Biomaterials Pty, Ltd. devices

Submission Details

510(k) Number K221686 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2022
Decision Date September 15, 2022
Days to Decision 97 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 114d · This submission: 97d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 18
Devices cleared under the same product code (QSZ) and FDA review panel - the closest regulatory comparables to K221686.
Redermo Wound Matrix
K260020 · Beijing Kreate Medical Co., Ltd. · Apr 2026
NovoSorb BTM
K251567 · Polynovo Biomaterials Pty, Ltd. · Jun 2025
NovoSorb® MTX
K242149 · Polynovo Biomaterials Pty, Ltd. · Mar 2025
SiOxD® Wound Matrix
K241660 · Sioxmed, LLC · Jul 2024
SiOxD Wound Matrix
K232847 · Sioxmed, LLC · Dec 2023
Restrata® MiniMatrix
K223725 · Acera Surgical, Inc. · May 2023