Cleared Traditional

K140359 - MAXIMIS SPINAL FIXATION SYSTEM

K140359 is an FDA 510(k) clearance for MAXIMIS SPINAL FIXATION SYSTEM, manufactured by Valorem Surgical. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 329-day FDA review.

K140359 · Valorem Surgical · Orthopedic device
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Jan 2015
Decision
329d
Days
Class 2
Risk

K140359 is an FDA 510(k) clearance for the MAXIMIS SPINAL FIXATION SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Valorem Surgical (Douglassville, US). The FDA issued a Cleared decision on January 7, 2015 after a review of 329 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. 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. Elevated predicate reliance profile. 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 Valorem Surgical devices

FDA 510(k) Submission Details - K140359

510(k) Number K140359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2014
Decision Date January 07, 2015
Days to Decision 329 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
207d slower than avg
Panel avg: 122d · This submission: 329d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNH Device Classification - Class 2, Special Controls

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 181
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K140359.
PASS LP Spinal System
K142798 · Medicrea International SA · Mar 2015
ANAX 5.5 Spinal System
K143417 · U&I Corporation · Feb 2015
PedFuse Pedicle Screw System
K143377 · Spinefrontier, Inc. · Feb 2015
INERTIA PEDICLE SCREW SYSTEM, HONOUR SPACER SYSTEM, FACET FIXX, STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS
K141376 · Nexxt Spine, LLC · Jun 2014
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K140948 · Spineart · May 2014
SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM
K133153 · Spinefrontier, Inc. · May 2014