Cleared Traditional

K052398 - MESA SPINAL SYSTEM

K052398 is an FDA 510(k) clearance for MESA SPINAL SYSTEM, manufactured by K2m, LLC. The device is a Class 2 Orthopedic device with product code MNI cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K052398 · K2m, LLC · Orthopedic device
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Dec 2005
Decision
98d
Days
Class 2
Risk

K052398 is an FDA 510(k) clearance for the MESA SPINAL SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by K2m, LLC (Leesburg, US). The FDA issued a Cleared decision on December 7, 2005 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all K2m, LLC devices

FDA 510(k) Submission Details - K052398

510(k) Number K052398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2005
Decision Date December 07, 2005
Days to Decision 98 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 122d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNI Device Classification - Class 2, Special Controls

Product Code MNI Orthosis, Spinal Pedicle 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 - MNI Orthosis, Spinal Pedicle Fixation

All 241
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K052398.
MODIFICATION TO S4 SPINAL SYSTEM
K060152 · Aesculap, Inc. · Feb 2006
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K053483 · Medtronic Sofamor Danek · Jan 2006
CAPLESS PEDICLE SCREW SYSTEM
K052847 · X-Spine Systems, Inc. · Dec 2005
XIA SPINAL SYSTEM
K053115 · Stryker Spine · Dec 2005
STRYKER SPINE TRIO SPINAL FIXATION SYSTEM
K052971 · Stryker Spine · Nov 2005
MODIFICATION TO: XIA 4.5 SPINAL SYSTEM
K052761 · Stryker Spine · Oct 2005