Cleared Traditional

POROUS HDPE SURGICAL IMPLANTS, TO BE DISTRIBUTED UNDER VARIOUS TRADEMARKS INCLUDING EPOR, BIOPOR, MINOPOR & P-HDPE (K022665) - FDA 510(k) Clearance

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

K022665 · Hohenstein Enterprises, Inc. · General & Plastic Surgery device
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Oct 2002
Decision
61d
Days
Class 2
Risk

K022665 is an FDA 510(k) clearance for the POROUS HDPE SURGICAL IMPLANTS, TO BE DISTRIBUTED UNDER VARIOUS TRADEMARKS INC.... Classified as Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction (product code KKY), Class II - Special Controls.

Submitted by Hohenstein Enterprises, Inc. (Los Angeles, US). The FDA issued a Cleared decision on October 9, 2002 after a review of 61 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3500 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hohenstein Enterprises, Inc. devices

Submission Details

510(k) Number K022665 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2002
Decision Date October 09, 2002
Days to Decision 61 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
54d faster than avg
Panel avg: 115d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3500
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.