Cleared Traditional

K041611 - SYNTHES (USA) RAPID RESORBABLE CRANIAL ...

K041611 is the FDA 510(k) clearance for SYNTHES (USA) RAPID RESORBABLE CRANIAL ... by Synthes (Usa). It is a Class 2 Neurology device (product code GXR) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K041611 · Synthes (Usa) · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2004
Decision
85d
Days
Class 2
Risk

K041611 is an FDA 510(k) clearance for the SYNTHES (USA) RAPID RESORBABLE CRANIAL CLAMP. Classified as Cover, Burr Hole (product code GXR), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on September 8, 2004 after a review of 85 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Synthes (Usa) devices

Submission Details

510(k) Number K041611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2004
Decision Date September 08, 2004
Days to Decision 85 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
63d faster than avg
Panel avg: 148d · This submission: 85d
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 15
Devices cleared under the same product code (GXR) and FDA review panel - the closest regulatory comparables to K041611.
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
AESCULAP ABSORBABLE CRANIOFIX
K040080 · Aesculap, Inc. · Mar 2004
SYNTHES RESORBABLE CRANIAL CLAMP, (MODIFIED)
K031654 · Synthes (Usa) · Aug 2003
RESORBABLE CRANIAL CLAMPS
K021408 · Synthes (Usa) · Jul 2002