Cleared Traditional

K172206 - NAJA Ligament Correction System

K172206 is the FDA 510(k) clearance for NAJA Ligament Correction System by Cousin Biotech Sas. It is a Class 2 Orthopedic device (product code OWI) cleared through the Traditional 510(k) pathway after a 263-day FDA review.

K172206 · Cousin Biotech Sas · Orthopedic device
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Apr 2018
Decision
263d
Days
Class 2
Risk

K172206 is an FDA 510(k) clearance for the NAJA™ Ligament Correction System. Classified as Bone Fixation Cerclage, Sublaminar (product code OWI), Class II - Special Controls.

Submitted by Cousin Biotech Sas (Wervicq-Sud, FR). The FDA issued a Cleared decision on April 10, 2018 after a review of 263 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3010 - 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 Cousin Biotech Sas devices

Submission Details

510(k) Number K172206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2017
Decision Date April 10, 2018
Days to Decision 263 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
141d slower than avg
Panel avg: 122d · This submission: 263d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OWI Bone Fixation Cerclage, Sublaminar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3010
Definition Acts As A Bone Anchor For Temporary Stabilization, Or Used In Conjunction With Other Medical Implants Of Similar Metals When Wiring Is Needed, During Development Of A Spinal 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 - OWI Bone Fixation Cerclage, Sublaminar

All 25
Devices cleared under the same product code (OWI) and FDA review panel - the closest regulatory comparables to K172206.
NuVasive® VersaTie® System
K190418 · Nu Vasive, Incorporated · Mar 2019
Spinal Elements Cerclage System
K180728 · Spinal Elements, Inc. · Sep 2018
ResCUBE™ Ligament Fixation System
K181799 · Cousin Biotech Sas · Aug 2018
LigaPASS
K173506 · Medicrea International SA · Apr 2018
NuVasive® VersaTie™ System
K173117 · Nuvasive, Inc. · Dec 2017
SILC® Fixation System
K172417 · Globus Medical, Inc. · Oct 2017