Cleared Special

K032344 - THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM MODEL 10-330

K032344 is an FDA 510(k) clearance for THE HEDROCEL TRABECULAR METAL RECONSTRU..., manufactured by Implex Corp.. The device is a Class 2 General & Plastic Surgery device with product code EZX cleared through the Special 510(k) pathway after a 64-day FDA review.

K032344 · Implex Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
64d
Days
Class 2
Risk

K032344 is an FDA 510(k) clearance for the THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM MODEL 10-330. Classified as Mesh, Surgical, Metal (product code EZX), Class II - Special Controls.

Submitted by Implex Corp. (Allendale, US). The FDA issued a Cleared decision on October 2, 2003 after a review of 64 days - a notably fast clearance cycle.

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. 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 Implex Corp. devices

FDA 510(k) Submission Details - K032344

510(k) Number K032344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2003
Decision Date October 02, 2003
Days to Decision 64 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 115d · This submission: 64d
Pathway characteristics
Modification to existing cleared device.

EZX Device Classification - Class 2, Special Controls

Product Code EZX Mesh, Surgical, Metal
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 - EZX Mesh, Surgical, Metal

All 8
Devices cleared under the same product code (EZX) and FDA review panel - the closest regulatory comparables to K032344.
OPTIMESH
K014200 · Spineology, Inc. · Nov 2003
MODIFICATION TO HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM
K032282 · Implex Corp. · Aug 2003
MACROPORE OS RECONSTRUCTION
K024169 · Macropore Biosurgery, Inc. · Jul 2003
THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM
K023882 · Implex Corp. · Feb 2003
NUVASIVE MESH
K020853 · Nuvasive, Inc. · Jun 2002
SYNTHES SYNMESH
K983766 · Synthes (Usa) · Dec 1998