Cleared Traditional

K042072 - CALLOS CMF BONE VOID FILLER

K042072 is an FDA 510(k) clearance for CALLOS CMF BONE VOID FILLER, manufactured by Skeletal Kinetics, LLC. The device is a Class 2 Neurology device with product code GXP cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K042072 · Skeletal Kinetics, LLC · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2004
Decision
45d
Days
Class 2
Risk

K042072 is an FDA 510(k) clearance for the CALLOS CMF BONE VOID FILLER. Classified as Methyl Methacrylate For Cranioplasty (product code GXP), Class II - Special Controls.

Submitted by Skeletal Kinetics, LLC (Cupertino, US). The FDA issued a Cleared decision on September 16, 2004 after a review of 45 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. 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 Skeletal Kinetics, LLC devices

FDA 510(k) Submission Details - K042072

510(k) Number K042072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2004
Decision Date September 16, 2004
Days to Decision 45 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 148d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 27
Devices cleared under the same product code (GXP) and FDA review panel - the closest regulatory comparables to K042072.
NORIAN CRS BONE CEMENT
K060445 · Synthes (Usa) · Apr 2006
BONE SOURCE HAC RAPID SETTING CEMENT
K043334 · Stryker Instruments · Feb 2005
MIMIX MP BONE VOID FILLER
K043280 · Biomet, Inc. · Dec 2004
SYNTHES (USA) CHRONOS
K041350 · Synthes (Usa) · Jul 2004
BONE CEMENT FOR CRANIOPLASTY
K040152 · Cardinalhealth · May 2004
BONESOURCE HAC FAST SETTING CEMENT
K032366 · Stryker Instruments · Oct 2003