Cleared Special

K012569 - MODIFICATION TO: INJECTABLE MIMIX

K012569 is an FDA 510(k) clearance for MODIFICATION TO: INJECTABLE MIMIX, manufactured by Biomet, Inc.. The device is a Class 2 Neurology device with product code GXP cleared through the Special 510(k) pathway after a 134-day FDA review.

K012569 · Biomet, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2001
Decision
134d
Days
Class 2
Risk

K012569 is an FDA 510(k) clearance for the MODIFICATION TO: INJECTABLE MIMIX. Classified as Methyl Methacrylate For Cranioplasty (product code GXP), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on December 21, 2001 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5300 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K012569

510(k) Number K012569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2001
Decision Date December 21, 2001
Days to Decision 134 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 149d · This submission: 134d
Pathway characteristics
Modification to existing cleared device.

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 44
Devices cleared under the same product code (GXP) and FDA review panel - the closest regulatory comparables to K012569.
BONESOURCE HAC
K021440 · Stryker Instruments · Aug 2002
FAST SET PUTTY
K012589 · Synthes (Usa) · Feb 2002
DRG QUICKMIX
K011736 · Doctor'S Research Group, Inc. · Jan 2002
PARALLAX CRANIOSET
K994022 · Parallax Medical, Inc. · Aug 2000
CRANIOFACIAL CALCIUM PHOSPHATE CERAMIC BONE FILLER
K990290 · Biomet, Inc. · Nov 1999
BONESOURCE HYDROXYAPATITE CEMENT (HAC) EXPANDED KIT
K991398 · Stryker Leibinger · Sep 1999
K012569 · MODIFICATION TO: INJECTABLE MIMIX
Download PDF FDA Summary Biomet, Inc.