Cleared Special

K033509 - MODIFICATION TO VERSABOND BONE CEMENT

K033509 is an FDA 510(k) clearance for MODIFICATION TO VERSABOND BONE CEMENT, manufactured by Smith & Nephew, Inc.. The device is a Class 2 Orthopedic device with product code LOD cleared through the Special 510(k) pathway after a 22-day FDA review.

K033509 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
22d
Days
Class 2
Risk

K033509 is an FDA 510(k) clearance for the MODIFICATION TO VERSABOND BONE CEMENT. Classified as Bone Cement (product code LOD), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on November 28, 2003 after a review of 22 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 - K033509

510(k) Number K033509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2003
Decision Date November 28, 2003
Days to Decision 22 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 122d · This submission: 22d
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 K033509.
SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT
K033382 · DePuy Orthopaedics, Inc. · Feb 2004
SMARTSET GHV GENTAMICIN BONE CEMENT
K033563 · DePuy Orthopaedics, Inc. · Feb 2004
PALACOS R BONE CEMENT WITH GENTAMICIN
K030086 · Biomet, Inc. · Dec 2003
DEPUY 1 GENTAMICIN BONE CEMENT
K023103 · DePuy Orthopaedics, Inc. · Sep 2003
PALACOS R
K030902 · Heraeus Kulzer GmbH & Co. KG · Sep 2003
OSTEOPAL
K030903 · Heraeus Kulzer GmbH & Co. KG · Sep 2003
K033509 · MODIFICATION TO VERSABOND BONE CEMENT
Download PDF FDA Summary Smith & Nephew, Inc.