Cleared Traditional

K130309 - RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM

K130309 is an FDA 510(k) clearance for RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM, manufactured by Biomet Microfixation. The device is a Class 2 Neurology device with product code GXR cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K130309 · Biomet Microfixation · Neurology device
Download Printable Device Report (PDF)
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Jun 2013
Decision
130d
Days
Class 2
Risk

K130309 is an FDA 510(k) clearance for the RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM. Classified as Cover, Burr Hole (product code GXR), Class II - Special Controls.

Submitted by Biomet Microfixation (Bartlett, US). The FDA issued a Cleared decision on June 17, 2013 after a review of 130 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5250 - 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 - K130309

510(k) Number K130309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2013
Decision Date June 17, 2013
Days to Decision 130 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
19d faster than avg
Panel avg: 149d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXR Device Classification - Class 2, Special Controls

Product Code GXR Cover, Burr Hole
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5250
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 - GXR Cover, Burr Hole

All 27
Devices cleared under the same product code (GXR) and FDA review panel - the closest regulatory comparables to K130309.
NEUROPACE BURR HOLE COVER
K141368 · NeuroPace, Inc. · Jul 2014
CRANIAL LOOP, CRANIAL LOOP L AND CRANIAL LOOP XL AND CRANIAL BONE FIXATION SYSTEM
K132044 · Neos Surgery S.L · Sep 2013
TRS CRANIAL BONE VOID FILLER(TRS C-BVF)
K123633 · Tissue Regeneration Systems, Inc. · Aug 2013
NEUROPACE BURR HOLE COVER MODEL 8110
K123163 · NeuroPace, Inc. · Jan 2013
CRANIAL LOOP CRANIAL BONE FIXATION SYSTEM
K101235 · Neos Surgery S.L · Oct 2010
AESCULAP PEEK CRANIOFIX
K091692 · Aesculap, Inc. · Aug 2010