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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 303
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K140359.
PedFuse Pedicle Screw System
K143377 · Spinefrontier, Inc. · Feb 2015
Ideal pedicle screw spinal system
K142957 · Jiangsu Ideal Medical Science & Technology Co., Ltd. · Jan 2015
CB PROT II Posterior Spinal System
K142655 · Chin Bone Technique Corp · Jan 2015
KangLi pedical screw spinal system
K142290 · Suzhou Kangli Orthopaedics Instrument Co., Ltd. · Nov 2014
GENERAL SPINAL SYSTEM
K134011 · Changzhou Dean Medical Instrument Co, Ltd. · Sep 2014
SPINEVISION LUMIS CANNULATED PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. PEDICLE SCREW FIXATION SYSTEM
K133575 · Spinevision S.A. · Jun 2014