Cleared Traditional

K003043 - SURGICAL TITANIUM MESH SYSTEM

K003043 is an FDA 510(k) clearance for SURGICAL TITANIUM MESH SYSTEM, manufactured by Depuyacromed. The device is a Class 2 Orthopedic device with product code MQP cleared through the Traditional 510(k) pathway after a 221-day FDA review.

K003043 · Depuyacromed · Orthopedic device
Download Printable Device Report (PDF)
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May 2001
Decision
221d
Days
Class 2
Risk

K003043 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 May 8, 2001 after a review of 221 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 Depuyacromed devices

FDA 510(k) Submission Details - K003043

510(k) Number K003043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2000
Decision Date May 08, 2001
Days to Decision 221 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
99d slower than avg
Panel avg: 122d · This submission: 221d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQP Device Classification - Class 2, Special Controls

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 K003043.
LIFT VB SPINAL SYSTEM
K010930 · Medtronic Sofamor Danek, Inc. · Oct 2001
GEO STRUCTURE
K010530 · Interpore Cross Intl. · Aug 2001
SURGICAL DYNAMICS MESH CAGE SYSTEM
K003709 · United States Surgical, A Division of Tyco Healthc · Jul 2001
SYNTHES SYNMESH SPACER SYSTEM
K003275 · Synthes (Usa) · Apr 2001
STACKABLE CAGE SYSTEM
K001340 · Depuyacromed · Jul 2000