Cleared Traditional

K090954 - ATLAS WOUND MATRIX

K090954 · Wrightmedicaltechnologyinc · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
115d
Days
-
Risk

K090954 is an FDA 510(k) clearance for the ATLAS WOUND MATRIX. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on July 30, 2009 after a review of 115 days - within the typical 510(k) review window.

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 - K090954

510(k) Number K090954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2009
Decision Date July 30, 2009
Days to Decision 115 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
At panel average
Panel avg: 115d · This submission: 115d
Pathway characteristics
Predicate-based equivalence.

KGN Device Classification - Class 0,

Product Code KGN Wound Dressing With Animal-derived Material(s)
Device Class -

Regulatory Peers - KGN Wound Dressing With Animal-derived Material(s)

All 194
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K090954.
THERAFORM BILAYER
K090823 · Sewon Cellontech Co., Ltd. · Oct 2009
COLLASORB COLLAGEN WOUND DRESSING
K091338 · Hartmann-Conco, Inc. · Aug 2009
THERAFORM STANDARD/SHEET
K090812 · Sewon Cellontech Co., Ltd. · Jul 2009
COLLAWOUND WOUND DRESSING
K090894 · Collamatrix Co., Inc. · Jun 2009
AONGEN COLLAGEN MATRIX
K080868 · Aeon Astron Europe B.V. · May 2009
AWBAT-S, AWBAT-D, AWBAT-M
K082869 · Aubrey, Inc. · Feb 2009
K090954 · ATLAS WOUND MATRIX
Download PDF FDA Summary Wrightmedicaltechnolo…