Cleared Traditional

K121624 - BIOMET MICROFIXATION NEURO PLATING SYSTEM

K121624 is an FDA 510(k) clearance for BIOMET MICROFIXATION NEURO PLATING SYSTEM, manufactured by Biomet Microfixation. The device is a Class 2 Neurology device with product code GWO cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K121624 · Biomet Microfixation · Neurology device
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Oct 2012
Decision
133d
Days
Class 2
Risk

K121624 is an FDA 510(k) clearance for the BIOMET MICROFIXATION NEURO PLATING SYSTEM. Classified as Plate, Cranioplasty, Preformed, Alterable (product code GWO), Class II - Special Controls.

Submitted by Biomet Microfixation (Jacksonville, US). The FDA issued a Cleared decision on October 12, 2012 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5320 - 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. Standard predicate reliance. 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 Biomet Microfixation devices

FDA 510(k) Submission Details - K121624

510(k) Number K121624 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2012
Decision Date October 12, 2012
Days to Decision 133 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
15d faster than avg
Panel avg: 148d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWO Device Classification - Class 2, Special Controls

Product Code GWO Plate, Cranioplasty, Preformed, Alterable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5320
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 - GWO Plate, Cranioplasty, Preformed, Alterable

All 32
Devices cleared under the same product code (GWO) and FDA review panel - the closest regulatory comparables to K121624.
UNIVERSAL NEURO 3 SYSTEM
K131775 · Stryker · Oct 2013
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K122049 · Kinamed, Inc. · Apr 2013
RESORB-X G
K121606 · KLS-Martin L.P. · Jan 2013
PEEK CUSTOMIZED CRAIAL IMPLANT KIT
K121153 · Stryker · Sep 2012
STRYKER QUIKFLAP STERILE PROCEDURE PACK
K120352 · Stryker · Jun 2012
LEFORTE NEURO SYSTEM BONE PLATE
K112812 · Jeil Medical Corporation · Feb 2012