Cleared Special

K080611 - MESA SPINAL SYSTEM

K080611 is the FDA 510(k) clearance for MESA SPINAL SYSTEM by K2m, Inc.. It is a Class 2 Orthopedic device (product code MNH) cleared through the Special 510(k) pathway after a 365-day FDA review.

K080611 · K2m, Inc. · Orthopedic device
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Mar 2009
Decision
365d
Days
Class 2
Risk

K080611 is an FDA 510(k) clearance for the MESA SPINAL SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by K2m, Inc. (Leesburg, US). The FDA issued a Cleared decision on March 4, 2009 after a review of 365 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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. Elevated predicate reliance 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 K080611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2008
Decision Date March 04, 2009
Days to Decision 365 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
243d slower than avg
Panel avg: 122d · This submission: 365d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MNH Orthosis, Spondylolisthesis Spinal Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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 - MNH Orthosis, Spondylolisthesis Spinal Fixation

All 154
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K080611.
MODIFICATION TO CAPSURE PS SYSTEM
K100122 · Spine Wave, Inc. · Feb 2010
FORTEX PEDICLE SCREW SYSTEM
K090224 · X-Spine Systems, Inc. · Jul 2009
ROC LUMBAR PLATING SYSTEM
K090228 · Alphatec Spine, Inc. · Apr 2009
ELLIPSE LUMBAR POSTERIOR OSTEOSYNTHESIS SYSTEM
K081165 · Spineart · Dec 2008
MOUNTAINEER OCT SPINAL SYSTEM
K080828 · Depuy Spine, Inc. · Jun 2008
RANGE SPINAL SYSTEM, LARGE DENALI SCREWS
K081381 · K2m, Inc. · Jun 2008