Cleared Traditional

K112684 - MONT BLANC PEDICLE SCREW SYSTEMS

K112684 is an FDA 510(k) clearance for MONT BLANC PEDICLE SCREW SYSTEMS, manufactured by Qualgenix. The device is a Class 2 Orthopedic device with product code NKB cleared through the Traditional 510(k) pathway after a 229-day FDA review.

K112684 · Qualgenix · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
229d
Days
Class 2
Risk

K112684 is an FDA 510(k) clearance for the MONT BLANC PEDICLE SCREW SYSTEMS. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Qualgenix (Oxford, US). The FDA issued a Cleared decision on May 1, 2012 after a review of 229 days - an extended review cycle.

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 Qualgenix devices

FDA 510(k) Submission Details - K112684

510(k) Number K112684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2011
Decision Date May 01, 2012
Days to Decision 229 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
107d slower than avg
Panel avg: 122d · This submission: 229d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NKB Device Classification - Class 2, Special Controls

Product Code NKB Thoracolumbosacral Pedicle Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.
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 - NKB Thoracolumbosacral Pedicle Screw System

All 747
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K112684.
SYNTHES MATRIX SYSTEM
K120928 · Synthes Spine · May 2012
SYNTHES USS CONNECTOR
K120571 · Synthes Spine · May 2012
VIPER SYSTEM
K121020 · Depuy Spine, Inc. · May 2012
TIGER SPINE SYSTEM
K113058 · Corelink, LLC · Mar 2012
VENUS SPINAL FIXATION SYSTEM
K120270 · L & K Biomed Co., Ltd. · Mar 2012
POWER ADAPTOR INSTRUMENT ACCESSORY
K120434 · Stryker Corp. · Mar 2012