Cleared Special

MESA AND RANGE SPINAL SYSTEMS (K082769) - FDA 510(k) Clearance

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

K082769 · K2m, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Dec 2008
Decision
80d
Days
Class 2
Risk

K082769 is an FDA 510(k) clearance for the MESA AND RANGE SPINAL SYSTEMS. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by K2m, Inc. (Leesburg, US). The FDA issued a Cleared decision on December 11, 2008 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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 K082769 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2008
Decision Date December 11, 2008
Days to Decision 80 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
42d faster than avg
Panel avg: 122d · This submission: 80d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 99
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K082769.
ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM
K090565 · Globus Medical, Inc. · Jun 2009
VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
K090714 · Medtronic Sofamor Danek · Apr 2009
VERTEX RECONTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
K082728 · Medtronic Sofamor Danek USA, Inc. · Jan 2009
PROTEX CT CERVICOTHORACIC SPINAL SYSTEM
K081906 · Globus Medical, Inc. · Nov 2008
VERTEX RECONSTRUCTION SYSTEM
K083071 · Medtronic Sofamor Danek · Nov 2008
VERTEX RECONSTRUCTION SYSTEM
K081297 · Medtronic Sofamor Danek · Jun 2008