Cleared Special

K081849 - BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE

K081849 is an FDA 510(k) clearance for BLACKSTONE PILLAR SA PARTIAL VERTEBRAL ..., manufactured by Blackstone Medical, Inc.. The device is a Class 2 Orthopedic device with product code OVD cleared through the Special 510(k) pathway after a 59-day FDA review.

K081849 · Blackstone Medical, Inc. · Orthopedic device
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Aug 2008
Decision
59d
Days
Class 2
Risk

K081849 is an FDA 510(k) clearance for the BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE. Classified as Intervertebral Fusion Device With Integrated Fixation, Lumbar (product code OVD), Class II - Special Controls.

Submitted by Blackstone Medical, Inc. (Wayne, US). The FDA issued a Cleared decision on August 28, 2008 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - 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

FDA 510(k) Submission Details - K081849

510(k) Number K081849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2008
Decision Date August 28, 2008
Days to Decision 59 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
63d faster than avg
Panel avg: 122d · This submission: 59d
Pathway characteristics
Modification to existing cleared device.

OVD Device Classification - Class 2, Special Controls

Product Code OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Lumbar Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation.
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 - OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

All 198
Devices cleared under the same product code (OVD) and FDA review panel - the closest regulatory comparables to K081849.
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