Cleared Special

K040756 - THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX (FDA 510(k) Clearance)

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

K040756 · Implex Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
112d
Days
Class 2
Risk

K040756 is an FDA 510(k) clearance for the THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX. Classified as Mesh, Surgical (product code FTM), Class II - Special Controls.

Submitted by Implex Corp. (Allendale, US). The FDA issued a Cleared decision on July 14, 2004 after a review of 112 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3300 - the FDA general and plastic surgery device 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Implex Corp. devices

Submission Details

510(k) Number K040756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2004
Decision Date July 14, 2004
Days to Decision 112 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 114d · This submission: 112d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FTM Mesh, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FTM Mesh, Surgical

All 162
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