Cleared Traditional

K030744 - BLACKSTONE SURGICAL TITANIUM MESH

K030744 is the FDA 510(k) clearance for BLACKSTONE SURGICAL TITANIUM MESH by Blackstone Medical, Inc.. It is a Class 2 Orthopedic device (product code MQP) cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K030744 · Blackstone Medical, Inc. · Orthopedic device
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Jun 2003
Decision
109d
Days
Class 2
Risk

K030744 is an FDA 510(k) clearance for the BLACKSTONE SURGICAL TITANIUM MESH. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Blackstone Medical, Inc. (Springfield, US). The FDA issued a Cleared decision on June 27, 2003 after a review of 109 days - within the typical 510(k) review window.

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 Blackstone Medical, Inc. devices

Submission Details

510(k) Number K030744 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2003
Decision Date June 27, 2003
Days to Decision 109 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
13d faster than avg
Panel avg: 122d · This submission: 109d
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 158
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K030744.
VERTE-STACK SPINAL SYSTEM
K031780 · Medtronic Sofamor Danek · Jul 2003
SPINAL CONCEPTS, INC. CADENCE AND FORTITUDE
K031914 · Spinal Concepts, Inc. · Jul 2003
HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1
K031823 · Implex Corp. · Jul 2003
SUSTAIN SPACER
K031302 · Globus Medical, Inc. · Jun 2003
DEPUY ACROMED VBR SYSTEM
K031635 · Depuyacromed · Jun 2003
MODIFIED VERTE-STACK SPINAL SYSTEM
K030735 · Medtronic Sofamor Danek · Apr 2003