Cleared Traditional

K924935 - HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT

K924935 is an FDA 510(k) clearance for HARD TISSUE REPLACE(HTR)-PATIENT-MATCH ..., manufactured by Polyclinic Medical Center. The device is a Class 2 General & Plastic Surgery device with product code KKY cleared through the Traditional 510(k) pathway after a 337-day FDA review.

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.

View all Polyclinic Medical Center devices

FDA 510(k) Submission Details - K924935

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
222d slower than avg
Panel avg: 115d · This submission: 337d
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 17
Devices cleared under the same product code (KKY) and FDA review panel - the closest regulatory comparables to K924935.
BONALIVE GRANULES AND BONALIVE PLATES
K071937 · Vivoxid , Ltd. · Oct 2007
STRYKER PATIENT SPECIFIC POLYMER IMPLANT
K043250 · Stryker Leibinger · Apr 2005
AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT, CEREPOR
K043133 · Ceremed , Inc. · Mar 2005
HTR POLYMER, HTR-MX
K904111 · United States Surgical, A Division of Tyco Healthc · Nov 1990
UHMWPE SURGICAL MESH
K894478 · Biomet, Inc. · Mar 1990
SURG. GOWN & DRAPE, LOW LINT TREATMENT
K781019 · Kimberly-Clark Corp. · Aug 1978