Cleared Traditional

K172206 - NAJA™ Ligament Correction System

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

K172206 · Cousin Biotech Sas · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K172206

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.

OWI Device Classification - Class 2, Special Controls

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 36
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