Cleared Traditional

K070012 - POLYBONE

K070012 is an FDA 510(k) clearance for POLYBONE, manufactured by Kyung Won Medical Co., Ltd.. The device is a Class 2 Neurology device with product code GXP cleared through the Traditional 510(k) pathway after a 358-day FDA review.

K070012 · Kyung Won Medical Co., Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2007
Decision
358d
Days
Class 2
Risk

K070012 is an FDA 510(k) clearance for the POLYBONE. Classified as Methyl Methacrylate For Cranioplasty (product code GXP), Class II - Special Controls.

Submitted by Kyung Won Medical Co., Ltd. (Santa Fe Springs, US). The FDA issued a Cleared decision on December 27, 2007 after a review of 358 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5300 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Kyung Won Medical Co., Ltd. devices

FDA 510(k) Submission Details - K070012

510(k) Number K070012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2007
Decision Date December 27, 2007
Days to Decision 358 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
210d slower than avg
Panel avg: 148d · This submission: 358d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXP Device Classification - Class 2, Special Controls

Product Code GXP Methyl Methacrylate For Cranioplasty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5300
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 Neurology devices follow this clearance model.

Regulatory Peers - GXP Methyl Methacrylate For Cranioplasty

All 32
Devices cleared under the same product code (GXP) and FDA review panel - the closest regulatory comparables to K070012.
DB-CMF
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DirectInject
K143661 · Stryker · Sep 2015
NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY
K102018 · Synthes USA Products, LLC · Sep 2010
MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280
K071791 · Codman & Shurtleff, Inc. · Jul 2007
STRYKER INJECTABLE CEMENT
K060763 · Stryker · Sep 2006
NORIAN CRS FAST SET PUTTY
K060443 · Synthes (Usa) · Apr 2006