Cleared Traditional

K161387 - Mont Blanc and Mont Blanc MIS Spinal Systems

K161387 is an FDA 510(k) clearance for Mont Blanc and Mont Blanc MIS Spinal Sy..., manufactured by Spineway SA. The device is a Class 2 Orthopedic device with product code NKB cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K161387 · Spineway SA · Orthopedic device
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Optimized for regulatory review, auditing and printing
Aug 2016
Decision
77d
Days
Class 2
Risk

K161387 is an FDA 510(k) clearance for the Mont Blanc and Mont Blanc MIS Spinal Systems. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Spineway SA (Ecully, FR). The FDA issued a Cleared decision on August 4, 2016 after a review of 77 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Spineway SA devices

FDA 510(k) Submission Details - K161387

510(k) Number K161387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2016
Decision Date August 04, 2016
Days to Decision 77 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
45d faster than avg
Panel avg: 122d · This submission: 77d
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 Consultant

Rich Jansen, Pharm.D.
Rich Jansen, Pharm.D.

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NKB Thoracolumbosacral Pedicle Screw System

All 874
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