Cleared Special

K041656 - MODIFICATION TO DEPUY 1 GENTAMICIN BONE CEMENT AND SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT

K041656 is an FDA 510(k) clearance for MODIFICATION TO DEPUY 1 GENTAMICIN BONE..., manufactured by DePuy Orthopaedics, Inc.. The device is a Class 2 Orthopedic device with product code LOD cleared through the Special 510(k) pathway after a 13-day FDA review.

K041656 · DePuy Orthopaedics, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
13d
Days
Class 2
Risk

K041656 is an FDA 510(k) clearance for the MODIFICATION TO DEPUY 1 GENTAMICIN BONE CEMENT AND SMARTSET GMV ENDURANCE GEN.... Classified as Bone Cement (product code LOD), Class II - Special Controls.

Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on July 1, 2004 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3027 - the FDA orthopedic device regulatory 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 - K041656

510(k) Number K041656 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2004
Decision Date July 01, 2004
Days to Decision 13 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 122d · This submission: 13d
Pathway characteristics
Modification to existing cleared device.

LOD Device Classification - Class 2, Special Controls

Product Code LOD Bone Cement
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3027
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 Orthopedic devices follow this clearance model.

Regulatory Peers - LOD Bone Cement

All 71
Devices cleared under the same product code (LOD) and FDA review panel - the closest regulatory comparables to K041656.
PALACOS LV+G
K050854 · Heraeus Kulzer,GmbH · Jul 2005
PALAMED G
K050855 · Heraeus Kulzer,GmbH · Jul 2005
CEMEX SYSTEM GENTA FAST BONE CEMENT
K043403 · Exactech, Inc. · Dec 2004
REFOBACIN -PALACOS G
K031673 · Heraeus Kulzer GmbH & Co. KG · May 2004
SIMPLEX X
K032945 · Stryker Corp. · May 2004
CEMEX GENTA BONE CEMENT
K033596 · Exactech, Inc. · May 2004
K041656 · MODIFICATION TO DEPUY 1 GENTAMICIN BONE CEMENT AND SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT
Download PDF FDA Summary DePuy Orthopaedics, I…