Cleared Traditional

CRANIOCLAMP BIOABSORBABLE CRANIAL BONE FLAP FIXATION SYSTEM (K071138) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K071138 · Prosurg, Inc. · Neurology device
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Aug 2007
Decision
152d
Days
Class 2
Risk

K071138 is an FDA 510(k) clearance for the CRANIOCLAMP BIOABSORBABLE CRANIAL BONE FLAP FIXATION SYSTEM. Classified as Cover, Burr Hole (product code GXR), Class II - Special Controls.

Submitted by Prosurg, Inc. (San Jose, US). The FDA issued a Cleared decision on August 15, 2007 after a review of 152 days - an extended review cycle.

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 Prosurg, Inc. devices

Submission Details

510(k) Number K071138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2007
Decision Date August 15, 2007
Days to Decision 152 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 148d · This submission: 152d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 13
Devices cleared under the same product code (GXR) and FDA review panel - the closest regulatory comparables to K071138.
OSSDSIGN Cranioplug
K181539 · Ossdsign AB · Oct 2018
GuardianTM Burr Hole Cover System
K181382 · St Jude Medical · Jul 2018
AESCULAP PEEK CRANIOFIX
K091692 · Aesculap, Inc. · Aug 2010
MODIFICATION TO SYNTHES (USA) (SYNTHES) LOW PROFILE NEURO SYSTEM
K042986 · Synthes (Usa) · Nov 2004
SYNTHES (USA) RAPID RESORBABLE CRANIAL CLAMP
K041611 · Synthes (Usa) · Sep 2004
AESCULAP ABSORBABLE CRANIOFIX
K040080 · Aesculap, Inc. · Mar 2004