Cleared Special

K082270 - OCTANE VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM

K082270 is an FDA 510(k) clearance for OCTANE VERTEBRAL BODY REPLACEMENT (VBR)..., manufactured by Vertiflex, Inc.. The device is a Class 2 Orthopedic device with product code MAX cleared through the Special 510(k) pathway after a 36-day FDA review.

K082270 · Vertiflex, Inc. · Orthopedic device
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Sep 2008
Decision
36d
Days
Class 2
Risk

K082270 is an FDA 510(k) clearance for the OCTANE VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM. Classified as Intervertebral Fusion Device With Bone Graft, Lumbar within the MAX classification (a category for intervertebral fusion devices and spinal implants), Class II - Special Controls.

Submitted by Vertiflex, Inc. (San Clamente, US). The FDA issued a Cleared decision on September 16, 2008 after a review of 36 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 Vertiflex, Inc. devices

FDA 510(k) Submission Details - K082270

510(k) Number K082270 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2008
Decision Date September 16, 2008
Days to Decision 36 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
86d faster than avg
Panel avg: 122d · This submission: 36d
Pathway characteristics
Modification to existing cleared device.

MAX Device Classification - Class 2, Special Controls

Product Code MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.
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 - MAX Intervertebral Fusion Device With Bone Graft, Lumbar

All 670
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K082270.
HOLLYWOOD, PACIFICA, REDONDO, VENTURA
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BLACKSTONE PILLAR XL PEEK SPACERS
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