Cleared Special

BLACKSTONE SURGICAL TITANIUM MESH SYSTEM ANGLED END RINGS (K032700) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K032700 · Blackstone Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
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 45
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K032700.
XPAND CORPECTOMY SPACER
K050850 · Globus Medical, Inc. · May 2005
SUSTAIN RADIOLUCENT SPACER
K040284 · Globus Medical, Inc. · Mar 2004
STRYKER SPINE VERTEBRAL BODY SUPPORT SYSTEM
K033837 · Howmedica Osteonics Corp. · Jan 2004
SUSTAIN SPACER
K031302 · Globus Medical, Inc. · Jun 2003
SYNTHES VERTEBRAL SPACER TI (CURVED AND NARROW)
K024364 · Synthes (Usa) · Mar 2003
VERTEBRAL SPACER
K011037 · Synthes (Usa) · Jul 2002