Cleared Traditional

K122225 - STERILE RADIOLUCENT SKULL PINS

K122225 is an FDA 510(k) clearance for STERILE RADIOLUCENT SKULL PINS, manufactured by Brainlab AG. The device is a Class 2 Neurology device with product code HBL cleared through the Traditional 510(k) pathway after a 275-day FDA review.

K122225 · Brainlab AG · Neurology device
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Apr 2013
Decision
275d
Days
Class 2
Risk

K122225 is an FDA 510(k) clearance for the STERILE RADIOLUCENT SKULL PINS. Classified as Holder, Head, Neurosurgical (skull Clamp) (product code HBL), Class II - Special Controls.

Submitted by Brainlab AG (Feldkirchen, DE). The FDA issued a Cleared decision on April 26, 2013 after a review of 275 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4460 - 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 Brainlab AG devices

FDA 510(k) Submission Details - K122225

510(k) Number K122225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2012
Decision Date April 26, 2013
Days to Decision 275 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
127d slower than avg
Panel avg: 148d · This submission: 275d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 38
Devices cleared under the same product code (HBL) and FDA review panel - the closest regulatory comparables to K122225.
TZ SKULL PIN Adult
K163322 · Tz Medical, Inc. · Feb 2017
MAYFIELD Skull Clamp
K142238 · Integra LifeSciences Corporation · Nov 2014
HFD100 ROCKER ARM ACCESSORY
K141950 · Imris, Inc. · Sep 2014
MAYFIELD INFINITY XR2 SKULL CLAMP
K130389 · Integra LifeSciences Corporation · Apr 2013
MAYFIELD SKULL CLAMP
K120633 · Integra LifeSciences Corporation · May 2012
IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD)
K113748 · Imris, Inc. · Mar 2012