Cleared Traditional

K013050 - THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM

K013050 is an FDA 510(k) clearance for THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM, manufactured by Bioplate, Inc.. The device is a Class 2 Neurology device with product code GXN cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K013050 · Bioplate, Inc. · Neurology device
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Dec 2001
Decision
90d
Days
Class 2
Risk

K013050 is an FDA 510(k) clearance for the THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM. Classified as Plate, Cranioplasty, Preformed, Non-alterable (product code GXN), Class II - Special Controls.

Submitted by Bioplate, Inc. (Los Angeles, US). The FDA issued a Cleared decision on December 10, 2001 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5330 - 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 Bioplate, Inc. devices

FDA 510(k) Submission Details - K013050

510(k) Number K013050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2001
Decision Date December 10, 2001
Days to Decision 90 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
58d faster than avg
Panel avg: 148d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXN Device Classification - Class 2, Special Controls

Product Code GXN Plate, Cranioplasty, Preformed, Non-alterable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5330
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 - GXN Plate, Cranioplasty, Preformed, Non-alterable

All 40
Devices cleared under the same product code (GXN) and FDA review panel - the closest regulatory comparables to K013050.
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MODIFICATION OF THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM
K020088 · Bioplate, Inc. · Feb 2002
MEDTRONIC INVISX BURR HOLE LOCK, MODEL 60520
K013000 · Medtronic Neurosurgery · Dec 2001
LEIBINGER QUIK DISK TITANIUM CLAMP SYSTEM
K993990 · Stryker Instruments · Feb 2000
SYNTHES CRANIAL FLAP TWIST CLAMP
K991860 · Synthes (Usa) · Jul 1999