Cleared Traditional

K011399 - BIOMET CRANIOFACIAL ACRYLIC CEMENT

K011399 is an FDA 510(k) clearance for BIOMET CRANIOFACIAL ACRYLIC CEMENT, manufactured by Biomet, Inc.. The device is a Class 2 Neurology device with product code GXP cleared through the Traditional 510(k) pathway after a 728-day FDA review.

K011399 · Biomet, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
728d
Days
Class 2
Risk

K011399 is an FDA 510(k) clearance for the BIOMET CRANIOFACIAL ACRYLIC CEMENT. 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 May 5, 2003 after a review of 728 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Biomet, Inc. devices

FDA 510(k) Submission Details - K011399

510(k) Number K011399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2001
Decision Date May 05, 2003
Days to Decision 728 days
Submission Type Traditional
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
580d slower than avg
Panel avg: 148d · This submission: 728d
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 39
Devices cleared under the same product code (GXP) and FDA review panel - the closest regulatory comparables to K011399.
BONE CEMENT FOR CRANIOPLASTY
K040152 · Cardinalhealth · May 2004
BONESOURCE HAC FAST SETTING CEMENT
K032366 · Stryker Instruments · Oct 2003
CAP BONE SUBSTITUTE MATERIAL
K032307 · Etex Corp. · Oct 2003
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