Cleared Special

K030249 - SURGICAL TITANIUM MESH SYSTEM

K030249 is the FDA 510(k) clearance for SURGICAL TITANIUM MESH SYSTEM by Depuyacromed. It is a Class 2 Orthopedic device (product code MQP) cleared through the Special 510(k) pathway after a 21-day FDA review.

K030249 · Depuyacromed · Orthopedic device
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Feb 2003
Decision
21d
Days
Class 2
Risk

K030249 is an FDA 510(k) clearance for the SURGICAL TITANIUM MESH SYSTEM. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Depuyacromed (Raynham, US). The FDA issued a Cleared decision on February 14, 2003 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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 Depuyacromed devices

Submission Details

510(k) Number K030249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2003
Decision Date February 14, 2003
Days to Decision 21 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
101d faster than avg
Panel avg: 122d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

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 161
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K030249.
SYNTHES VERTEBRAL SPACER TI (CURVED AND NARROW)
K024364 · Synthes (Usa) · Mar 2003
NUVASIVE MASH
K023319 · Nuvasive, Inc. · Mar 2003
VERTE-SPAN SPINAL SYSTEM
K024049 · Medtronic Sofamor Danek, Inc. · Feb 2003
DEVEX MESH SYSTEM
K023835 · Depuyacromed · Jan 2003
INTERPORE CROSS INTERNATIONAL ANTERIOR FIXATION DEVICE (AFD)
K022143 · Interpore Cross Intl. · Jan 2003
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K023570 · Medtronic Sofamor Danek · Nov 2002