Cleared Traditional

K243302 - 3DMatrix DynaFlex (DynaFlex) (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K243302 · Printbio, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
215d
Days
Class 2
Risk

K243302 is an FDA 510(k) clearance for the 3DMatrix DynaFlex (DynaFlex). 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 21, 2025 after a review of 215 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

Submission Details

510(k) Number K243302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2024
Decision Date May 21, 2025
Days to Decision 215 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
101d slower than avg
Panel avg: 114d · This submission: 215d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.