Cleared Special

K080024 - ALEUTIAN SPACER, MODEL K2-07-1004-01, K2-07-1005-01

K080024 is an FDA 510(k) clearance for ALEUTIAN SPACER, manufactured by K2m, Inc.. The device is a Class 2 Orthopedic device with product code MQP cleared through the Special 510(k) pathway after a 20-day FDA review.

K080024 · K2m, Inc. · Orthopedic device
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Jan 2008
Decision
20d
Days
Class 2
Risk

K080024 is an FDA 510(k) clearance for the ALEUTIAN SPACER, MODEL K2-07-1004-01, K2-07-1005-01. 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 January 24, 2008 after a review of 20 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 K2m, Inc. devices

FDA 510(k) Submission Details - K080024

510(k) Number K080024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 2008
Decision Date January 24, 2008
Days to Decision 20 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
102d faster than avg
Panel avg: 122d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

MQP Device Classification - Class 2, Special Controls

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 270
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K080024.
VERTEBRON VBR SYSTEM
K073502 · Vertebron, Inc. · Mar 2008
KIMBA MINI
K080349 · Signus Medizintechnik GmbH · Mar 2008
BENGAL STACKABLE CAGE SYSTEM
K073649 · Depuy Spine, Inc. · Jan 2008
MODIFICATION TO VALEO VBR
K073505 · Amedica Corp. · Jan 2008
CREASPINE SUPSTANCE VERTEBRAL BODY REPLACEMENT SYSTEM
K072537 · Creaspine Sas · Dec 2007
VALEO VBR
K073125 · Amedica Corp. · Dec 2007