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) Official FDA 510(k) Summary (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.

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 24
Devices cleared under the same product code (KKY) and FDA review panel - the closest regulatory comparables to K934861.
POROUS HDPE SURGICAL IMPLANTS, TO BE DISTRIBUTED UNDER VARIOUS TRADEMARKS INCLUDING EPOR, BIOPOR, MINOPOR & P-HDPE
K022665 · Hohenstein Enterprises, Inc. · Oct 2002
IMMIX BONE GRAFT EXTENDER
K013764 · Osteogenics Biomedical, Inc. · May 2002
TLC SURGICAL DRAPES
K951474 · Tlc Tech Lab Clothes, Inc. · Aug 1995
SURGICAL APPAREL
K935199 · Associated Hospital Services, Inc. · Sep 1994
HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT
K924935 · Polyclinic Medical Center · Sep 1993
MAALEABLE FACIAL IMPLANT
K915445 · Biomet Ussc Orthopedics · Feb 1992
K934861 · HARD TISSUE REPLACEMENT (HTR) GRANULAR
Download PDF FDA Summary Poly-Medics,Inc.