Cleared Special

MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280 (K071791) - FDA 510(k) Clearance

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K071791 · Codman & Shurtleff, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2007
Decision
28d
Days
Class 2
Risk

K071791 is an FDA 510(k) clearance for the MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280. Classified as Methyl Methacrylate For Cranioplasty (product code GXP), Class II - Special Controls.

Submitted by Codman & Shurtleff, Inc. (Raynham, US). The FDA issued a Cleared decision on July 30, 2007 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5300 - 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.

View all Codman & Shurtleff, Inc. devices

Submission Details

510(k) Number K071791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2007
Decision Date July 30, 2007
Days to Decision 28 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
120d faster than avg
Panel avg: 148d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GXP Methyl Methacrylate For Cranioplasty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5300
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 - GXP Methyl Methacrylate For Cranioplasty

All 42
Devices cleared under the same product code (GXP) and FDA review panel - the closest regulatory comparables to K071791.
Permatage Flowable, Settable Bone Paste
K253732 · Orthocon, Inc. · Mar 2026
MONTAGE XT Cranial Cement
K253854 · Orthocon, Inc. · Jan 2026
Permatage Settable Bone Putty
K241027 · Orthocon, Inc. · Sep 2024
Montage Flowable Settable, Resorbable Bone Paste
K232771 · Orthocon, Inc. · Feb 2024
MONTAGE-QS Settable, Resorbable Bone Putty
K231475 · Orthocon, Inc. · Oct 2023
MONTAGE Settable, Resorbable Bone Putty
K221933 · Orthocon, Inc. · Jan 2023