Cleared Special

K032700 - BLACKSTONE SURGICAL TITANIUM MESH SYSTE...

K032700 is the FDA 510(k) clearance for BLACKSTONE SURGICAL TITANIUM MESH SYSTE... by Blackstone Medical, Inc.. It is a Class 2 Orthopedic device (product code MQP) cleared through the Special 510(k) pathway after a 37-day FDA review.

K032700 · Blackstone Medical, Inc. · Orthopedic device
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Oct 2003
Decision
37d
Days
Class 2
Risk

K032700 is an FDA 510(k) clearance for the BLACKSTONE SURGICAL TITANIUM MESH SYSTEM ANGLED END RINGS. 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 October 9, 2003 after a review of 37 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 Blackstone Medical, Inc. devices

Submission Details

510(k) Number K032700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2003
Decision Date October 09, 2003
Days to Decision 37 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
85d faster than avg
Panel avg: 122d · This submission: 37d
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 158
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K032700.
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
SPINAL CONCEPTS, INC. INFIX SYSTEM
K031672 · Spinal Concepts, Inc. · Aug 2003
VERTE-STACK SPINAL SYSTEM
K031780 · Medtronic Sofamor Danek · Jul 2003
SPINAL CONCEPTS, INC. CADENCE AND FORTITUDE
K031914 · Spinal Concepts, Inc. · Jul 2003