Cleared Special

K063399 - ALEUTIAN SPACER SYSTEM (FDA 510(k) Clearance)

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

K063399 · K2m, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
106d
Days
Class 2
Risk

K063399 is an FDA 510(k) clearance for the ALEUTIAN SPACER SYSTEM. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by K2m, Inc. (Leesburg, US). The FDA issued a Cleared decision on February 23, 2007 after a review of 106 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all K2m, Inc. devices

Submission Details

510(k) Number K063399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2006
Decision Date February 23, 2007
Days to Decision 106 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
16d faster than avg
Panel avg: 122d · This submission: 106d
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 276
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K063399.
VyBrate™ VBR System
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Vertiwedge® Intraosseous System
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KONG®-TL VBR System and KONG® C VBR System
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DOMINION Expandable Corpectomy System
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VerteLoc Spinal System
K231134 · Signature Orthopaedics Pty, Ltd. · Feb 2024
Ascend VBR System, Ascend NanoTec VBR System
K232173 · Alphatec Spine, Inc. · Oct 2023