Cleared Traditional

K934861 - HARD TISSUE REPLACEMENT (HTR) GRANULAR

K934861 is an FDA 510(k) clearance for HARD TISSUE REPLACEMENT (HTR) GRANULAR, manufactured by Poly-Medics,Inc.. The device is a Class 2 General & Plastic Surgery device with product code KKY cleared through the Traditional 510(k) pathway after a 388-day FDA review.

K934861 · Poly-Medics,Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1994
Decision
388d
Days
Class 2
Risk

K934861 is an FDA 510(k) clearance for the HARD TISSUE REPLACEMENT (HTR) GRANULAR. Classified as Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction (product code KKY), Class II - Special Controls.

Submitted by Poly-Medics,Inc. (Warsaw, US). The FDA issued a Cleared decision on November 4, 1994 after a review of 388 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 Poly-Medics,Inc. devices

FDA 510(k) Submission Details - K934861

510(k) Number K934861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1993
Decision Date November 04, 1994
Days to Decision 388 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
273d slower than avg
Panel avg: 115d · This submission: 388d
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 9
Devices cleared under the same product code (KKY) and FDA review panel - the closest regulatory comparables to K934861.
STRYKER PATIENT SPECIFIC POLYMER IMPLANT
K103010 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Oct 2010
AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT
K080507 · Ceremed , Inc. · Apr 2008
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