Cleared Traditional

K232602 - 3DMatrix Surgical Mesh

K232602 is an FDA 510(k) clearance for 3DMatrix Surgical Mesh, manufactured by Printbio, Inc.. The device is a Class 2 General & Plastic Surgery device with product code OXF cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K232602 · Printbio, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2024
Decision
269d
Days
Class 2
Risk

K232602 is an FDA 510(k) clearance for the 3DMatrix Surgical Mesh. Classified as Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery (product code OXF), Class II - Special Controls.

Submitted by Printbio, Inc. (Long Island City, US). The FDA issued a Cleared decision on May 23, 2024 after a review of 269 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3300 - the FDA general and plastic surgery device framework. 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 Printbio, Inc. devices

FDA 510(k) Submission Details - K232602

510(k) Number K232602 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2023
Decision Date May 23, 2024
Days to Decision 269 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
154d slower than avg
Panel avg: 115d · This submission: 269d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OXF Device Classification - Class 2, Special Controls

Product Code OXF Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
Definition For Reinforcement Of Soft Tissue Where Weakness Exists In Plastic And Reconstructive Surgery.
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - OXF Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery

Devices cleared under the same product code (OXF) and FDA review panel - the closest regulatory comparables to K232602.
Restrata Soft Tissue Reinforcement (STR)
K251224 · Acera Surgical, Inc. · Jun 2025
3DMatrix DynaFlex (DynaFlex)
K243302 · Printbio, Inc. · May 2025
GORE® ENFORM Biomaterial
K222919 · W. L. Gore and Associates, Inc. · Dec 2022
GORE ENFORM Biomaterial
K173333 · W.L. Gore & Associates, Inc. · Apr 2018
GORE BIO-A Tissue Reinforcement
K163217 · W.L. Gore & Associates, Inc. · Feb 2017