Cleared Special

ALEUTIAN IBF SYSTEM (K101302) - FDA 510(k) Clearance

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

K101302 · K2m, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2010
Decision
73d
Days
Class 2
Risk

K101302 is an FDA 510(k) clearance for the ALEUTIAN IBF SYSTEM. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by K2m, Inc. (Leesburg, US). The FDA issued a Cleared decision on July 22, 2010 after a review of 73 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 K2m, Inc. devices

Submission Details

510(k) Number K101302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2010
Decision Date July 22, 2010
Days to Decision 73 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
49d faster than avg
Panel avg: 122d · This submission: 73d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code ODP Intervertebral Fusion Device With Bone Graft, Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Cervical 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 - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 177
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K101302.
ANATOMIC PEEK CERVICAL FUSION SYSTEM
K130177 · Medtronic Sofamor Danek USA, Inc. · Sep 2013
PERIMETER C SPINAL SYSTEM
K100967 · Medtronic Sofamor Danek USA, Inc. · Aug 2011
OCTANE-C INTERBODY FUSION DEVICE SYSTEM
K103655 · Exactech, Inc. · Jun 2011
PATRIOT SPACERS: COLONIAL ACDF
K072991 · Globus Medical, Inc. · Jan 2008