Cleared Traditional

K021889 - SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.)

K021889 is an FDA 510(k) clearance for SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.), manufactured by Surgical Technology Laboratories, Inc.. The device is a Class 2 General & Plastic Surgery device with product code KKY cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K021889 · Surgical Technology Laboratories, Inc. · General & Plastic Surgery device
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Oct 2002
Decision
131d
Days
Class 2
Risk

K021889 is an FDA 510(k) clearance for the SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.). Classified as Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction (product code KKY), Class II - Special Controls.

Submitted by Surgical Technology Laboratories, Inc. (Cleveland, US). The FDA issued a Cleared decision on October 16, 2002 after a review of 131 days - within the typical 510(k) review window.

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: 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 - K021889

510(k) Number K021889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2002
Decision Date October 16, 2002
Days to Decision 131 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 115d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KKY Device Classification - Class 2, Special Controls

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.

Regulatory Peers - KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction

All 23
Devices cleared under the same product code (KKY) and FDA review panel - the closest regulatory comparables to K021889.
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