Cleared Traditional

K924935 - HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT (FDA 510(k) Clearance)

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

K924935 · Polyclinic Medical Center · General & Plastic Surgery device
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Sep 1993
Decision
337d
Days
Class 2
Risk

K924935 is an FDA 510(k) clearance for the HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT. Classified as Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction (product code KKY), Class II - Special Controls.

Submitted by Polyclinic Medical Center (Warsaw, US). The FDA issued a Cleared decision on September 2, 1993 after a review of 337 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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.

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Submission Details

510(k) Number K924935 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1992
Decision Date September 02, 1993
Days to Decision 337 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
223d slower than avg
Panel avg: 114d · This submission: 337d
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.