Cleared Special

K071791 - MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280

K071791 is an FDA 510(k) clearance for MODIFICATION TO CRANIOPLASTIC, manufactured by Codman & Shurtleff, Inc.. The device is a Class 2 Neurology device with product code GXP cleared through the Special 510(k) pathway after a 28-day FDA review.

K071791 · Codman & Shurtleff, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K071791

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
121d faster than avg
Panel avg: 149d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

GXP Device Classification - Class 2, Special Controls

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 44
Devices cleared under the same product code (GXP) and FDA review panel - the closest regulatory comparables to K071791.
KRYPTONITE BONE CEMENT
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POLYBONE
K070012 · Kyung Won Medical Co., Ltd. · Dec 2007
OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANT
K072601 · Osteosymbionics, LLC · Dec 2007
STRYKER INJECTABLE CEMENT
K060763 · Stryker · Sep 2006
NORIAN CRS FAST SET PUTTY
K060443 · Synthes (Usa) · Apr 2006
NORIAN CRS BONE CEMENT
K060445 · Synthes (Usa) · Apr 2006
K071791 · MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280
Download PDF FDA Summary Codman & Shurtleff, I…