Cleared Traditional

K011736 - DRG QUICKMIX

K011736 is an FDA 510(k) clearance for DRG QUICKMIX, manufactured by Doctor'S Research Group, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GXP cleared through the Traditional 510(k) pathway after a 239-day FDA review.

K011736 · Doctor'S Research Group, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
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Jan 2002
Decision
239d
Days
Class 2
Risk

K011736 is an FDA 510(k) clearance for the DRG QUICKMIX. Classified as Methyl Methacrylate For Cranioplasty (product code GXP), Class II - Special Controls.

Submitted by Doctor'S Research Group, Inc. (Wolcott, US). The FDA issued a Cleared decision on January 30, 2002 after a review of 239 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 882.5300 - 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. Standard predicate reliance. 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 Doctor'S Research Group, Inc. devices

FDA 510(k) Submission Details - K011736

510(k) Number K011736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2001
Decision Date January 30, 2002
Days to Decision 239 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
124d slower than avg
Panel avg: 115d · This submission: 239d
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GXP Methyl Methacrylate For Cranioplasty

All 40
Devices cleared under the same product code (GXP) and FDA review panel - the closest regulatory comparables to K011736.
QUICKSET MIMIX BONE VOID FILLER
K023718 · Walter Lorenz Surgical, Inc. · Dec 2002
BONESOURCE HAC
K021440 · Stryker Instruments · Aug 2002
FAST SET PUTTY
K012589 · Synthes (Usa) · Feb 2002
MODIFICATION TO: INJECTABLE MIMIX
K012569 · Biomet, Inc. · Dec 2001
PARALLAX CRANIOSET
K994022 · Parallax Medical, Inc. · Aug 2000
CRANIOFACIAL CALCIUM PHOSPHATE CERAMIC BONE FILLER
K990290 · Biomet, Inc. · Nov 1999