Cleared Traditional

Idys™ ALIF System (K172083) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K172083 · Clariance, Sas · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2017
Decision
121d
Days
Class 2
Risk

K172083 is an FDA 510(k) clearance for the Idys™ ALIF System. Classified as Intervertebral Fusion Device With Integrated Fixation, Lumbar (product code OVD), Class II - Special Controls.

Submitted by Clariance, Sas (Beaurains, FR). The FDA issued a Cleared decision on November 8, 2017 after a review of 121 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - 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 Clariance, Sas devices

Submission Details

510(k) Number K172083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2017
Decision Date November 08, 2017
Days to Decision 121 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
1d faster than avg
Panel avg: 122d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Lumbar Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation.
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 - OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

All 116
Devices cleared under the same product code (OVD) and FDA review panel - the closest regulatory comparables to K172083.
SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu a•POD Prime Intervertebral Body Fusion Device
K173606 · SeaSpine Orthopedics Corporation · Apr 2018
Arco™-SA Lumbar Cage System
K173082 · Neurostructures, Inc. · Mar 2018
CASCADIA Interbody System
K172941 · K2m · Feb 2018
SOVEREIGN™ Spinal System
K172328 · Medtronic Sofamor Danek USA, Inc. · Nov 2017
INDEPENDENCE® Spacers
K170157 · Globus Medical, Inc. · Sep 2017
NuVasive BASE Interfixated Titanium System
K170592 · Nu Vasive, Incorporated · Apr 2017