Cleared Traditional

K071138 - CRANIOCLAMP BIOABSORBABLE CRANIAL BONE ...

K071138 is an FDA 510(k) clearance for CRANIOCLAMP BIOABSORBABLE CRANIAL BONE ..., manufactured by Prosurg, Inc.. The device is a Class 2 Neurology device with product code GXR cleared through the Traditional 510(k) pathway after a 152-day FDA review.

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

FDA 510(k) Submission Details - K071138

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.

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 16
Devices cleared under the same product code (GXR) and FDA review panel - the closest regulatory comparables to K071138.
GuardianTM Burr Hole Cover System
K181382 · St Jude Medical · Jul 2018
Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover
K152342 · St Jude Medical · Jun 2016
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