Cleared Traditional

K170213 - SupraSDRM Biodegradable Matrix Wound Dressing

K170213 · Polymedics Innovations, GmbH · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2017
Decision
155d
Days
-
Risk

K170213 is an FDA 510(k) clearance for the SupraSDRM Biodegradable Matrix Wound Dressing. Classified as Absorbable Synthetic Wound Dressing (product code QSZ).

Submitted by Polymedics Innovations, GmbH (Denkendorf, DE). The FDA issued a Cleared decision on June 28, 2017 after a review of 155 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.

FDA 510(k) Submission Details - K170213

510(k) Number K170213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2017
Decision Date June 28, 2017
Days to Decision 155 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
40d slower than avg
Panel avg: 115d · This submission: 155d
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 20
Devices cleared under the same product code (QSZ) and FDA review panel - the closest regulatory comparables to K170213.
Restrata®
K193583 · Acera Surgical, Inc. · Sep 2020
Phoenix Wound Matrix
K173544 · Nanofiber Solutions, Inc. · Mar 2018
NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x 20cm), NovoSorb BTM Wound Dressing (20cm x 40cm)
K172140 · Polynovo Biomaterials Pty, Ltd. · Aug 2017
Restrata Wound Matrix
K170300 · Acera Surgical, Inc. · Apr 2017
Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6”
K161067 · Engineered Tissue Solutions, LLC · Sep 2016
BTM Wound Dressing
K142879 · Polynovo Biomaterials Pty, Ltd. · Dec 2015
K170213 · SupraSDRM Biodegradable Matrix Wound Dressing
Download PDF FDA Summary Polymedics Innovation…