Cleared Traditional

K023882 - THE HEDROCEL TRABECULAR METAL RECONSTRU...

K023882 is the FDA 510(k) clearance for THE HEDROCEL TRABECULAR METAL RECONSTRU... by Implex Corp.. It is a Class 2 General & Plastic Surgery device (product code EZX) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K023882 · Implex Corp. · General & Plastic Surgery device
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Feb 2003
Decision
90d
Days
Class 2
Risk

K023882 is an FDA 510(k) clearance for the THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM. 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 February 19, 2003 after a review of 90 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Implex Corp. devices

Submission Details

510(k) Number K023882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2002
Decision Date February 19, 2003
Days to Decision 90 days
Submission Type Traditional
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
25d faster than avg
Panel avg: 115d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

Devices cleared under the same product code (EZX) and FDA review panel - the closest regulatory comparables to K023882.
OPTIMESH
K014200 · Spineology, Inc. · Nov 2003
THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM MODEL 10-330
K032344 · Implex Corp. · Oct 2003
MODIFICATION TO HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM
K032282 · Implex Corp. · Aug 2003
NUVASIVE MESH
K020853 · Nuvasive, Inc. · Jun 2002
SYNTHES SYNMESH
K983766 · Synthes (Usa) · Dec 1998
TROCHANTER MESH
K945027 · Acu Med, Inc. · Feb 1995