Cleared Special

CEMEX SYSTEM FAST (K031430) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K031430 · Exactech, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
16d
Days
Class 2
Risk

K031430 is an FDA 510(k) clearance for the CEMEX SYSTEM FAST. Classified as Bone Cement (product code LOD), Class II - Special Controls.

Submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on May 22, 2003 after a review of 16 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.

View all Exactech, Inc. devices

Submission Details

510(k) Number K031430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2003
Decision Date May 22, 2003
Days to Decision 16 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
106d faster than avg
Panel avg: 122d · This submission: 16d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 46
Devices cleared under the same product code (LOD) and FDA review panel - the closest regulatory comparables to K031430.
PALACOS R BONE CEMENT WITH GENTAMICIN
K030086 · Biomet, Inc. · Dec 2003
MODIFICATION TO VERSABOND BONE CEMENT
K033509 · Smith & Nephew, Inc. · Nov 2003
DEPUY 1 GENTAMICIN BONE CEMENT
K023103 · DePuy Orthopaedics, Inc. · Sep 2003
SURGICAL SIMPLEX P WITH TOBRAMYCIN
K014199 · Howmedica Osteonics Corp. · May 2003
SMARTSET HV BONE CEMENT
K023012 · DePuy Orthopaedics, Inc. · Feb 2003
CEMVAC ULTRA PRE-PACKED WITH DEPUY 1 BONE CEMENT
K021499 · DePuy Orthopaedics, Inc. · Jul 2002