Cleared Traditional

K162367 - Erisma LP MIS

K162367 is an FDA 510(k) clearance for Erisma LP MIS, manufactured by Clariance, Sas. The device is a Class 2 Orthopedic device with product code NKB cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K162367 · Clariance, Sas · Orthopedic device
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Oct 2016
Decision
65d
Days
Class 2
Risk

K162367 is an FDA 510(k) clearance for the Erisma® LP MIS. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Clariance, Sas (Beaurains, FR). The FDA issued a Cleared decision on October 27, 2016 after a review of 65 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 Clariance, Sas devices

FDA 510(k) Submission Details - K162367

510(k) Number K162367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2016
Decision Date October 27, 2016
Days to Decision 65 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
57d faster than avg
Panel avg: 122d · This submission: 65d
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 714
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K162367.
ENNOVATE Spinal System
K162134 · Aesculap Implant Systems, LLC · Dec 2016
VIPER PRIME™ additions to the VIPER® System
K162912 · Medos International SARL · Dec 2016
CD HORIZON® Spinal System
K162379 · Medtronic Sofamor Danek USA, Inc. · Nov 2016
M.U.S.T. Pedicle Screw System
K162061 · Medacta International S.A. · Oct 2016
CD HORIZON® Spinal System
K162494 · Medtronic Sofamor Danek USA, Inc. · Oct 2016
NuVasive® Reline® System
K161014 · Nu Vasive, Incorporated · Sep 2016