Cleared Traditional

K032371 - TITANIUM MESH SYSTEM

K032371 is the FDA 510(k) clearance for TITANIUM MESH SYSTEM by Encore Medical, L.P.. It is a Class 2 Orthopedic device (product code MQP) cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K032371 · Encore Medical, L.P. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Feb 2004
Decision
195d
Days
Class 2
Risk

K032371 is an FDA 510(k) clearance for the TITANIUM MESH SYSTEM. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Encore Medical, L.P. (Austin, US). The FDA issued a Cleared decision on February 12, 2004 after a review of 195 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - the FDA orthopedic device regulatory 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 Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Encore Medical, L.P. devices

Submission Details

510(k) Number K032371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2003
Decision Date February 12, 2004
Days to Decision 195 days
Submission Type Traditional
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
73d slower than avg
Panel avg: 122d · This submission: 195d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MQP Spinal Vertebral Body Replacement Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - MQP Spinal Vertebral Body Replacement Device

All 152
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K032371.
SUSTAIN RADIOLUCENT SPACER
K040284 · Globus Medical, Inc. · Mar 2004
MODIFICATION TO VERTE-STACK
K040422 · Medtronic Sofamor Danek · Mar 2004
VERTE-STACK SPINAL SYSTEM
K040167 · Medtronic Sofamor Danek · Feb 2004
STRYKER SPINE VERTEBRAL BODY SUPPORT SYSTEM
K033837 · Howmedica Osteonics Corp. · Jan 2004
NUVASIVE MESH
K032476 · Nuvasive, Inc. · Nov 2003
HEDROCEL VERTEBRAL BODY REPLACEMENT
K032527 · Implex Corp. · Oct 2003