Cleared Special

K053045 - MODIFICATION TO: MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020

K053045 is an FDA 510(k) clearance for MODIFICATION TO: MAYFIELD RADIOLUCENT S..., manufactured by Integra LifeSciences Corporation. The device is a Class 2 Neurology device with product code HBL cleared through the Special 510(k) pathway after a 24-day FDA review.

K053045 · Integra LifeSciences Corporation · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2005
Decision
24d
Days
Class 2
Risk

K053045 is an FDA 510(k) clearance for the MODIFICATION TO: MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020. Classified as Holder, Head, Neurosurgical (skull Clamp) (product code HBL), Class II - Special Controls.

Submitted by Integra LifeSciences Corporation (Planisboro, US). The FDA issued a Cleared decision on November 21, 2005 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4460 - 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. Low regulatory complexity profile. 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 - K053045

510(k) Number K053045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 2005
Decision Date November 21, 2005
Days to Decision 24 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
125d faster than avg
Panel avg: 149d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

HBL Device Classification - Class 2, Special Controls

Product Code HBL Holder, Head, Neurosurgical (skull Clamp)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4460
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 - HBL Holder, Head, Neurosurgical (skull Clamp)

All 50
Devices cleared under the same product code (HBL) and FDA review panel - the closest regulatory comparables to K053045.
MAYFIELD DISPOSABLE AND REUSABLE TITANIUM SKULL PINS
K072208 · Integra LifeSciences Corporation · Sep 2007
MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS
K071458 · Integra LifeSciences Corporation · Jun 2007
DORO RADIOLUCENT HEADREST SYSTEM ( ALSO MRI-COMPATIBLE) AND COMPONENTS
K063494 · Pro-Med Instruments GmbH · May 2007
MAYFIELD INFINITY SKULL CLAMP
K051440 · Integra Lifesciences Corp. · Sep 2005
MAYFIELD MR/CT SKULL CLAMP, MODEL 4-0-A-1104
K050319 · Integra Lifesciences Corp. · Mar 2005
DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS,AND NON-RADIOLUCENT J-ARM RETRACTOR SYSTEM (ALUMINUM ALLOY)
K032331 · Pro-Med Instruments GmbH · Nov 2003
K053045 · MODIFICATION TO: MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020
Download PDF FDA Summary Integra LifeSciences …