Cleared Traditional

Ortus™ Expandable Lumbar Interbody Fusion System (K172334) - FDA 510(k) Clearance

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

K172334 · Atlas Spine, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2017
Decision
84d
Days
Class 2
Risk

K172334 is an FDA 510(k) clearance for the Ortus™ Expandable Lumbar Interbody Fusion System. Classified as Intervertebral Fusion Device With Bone Graft, Lumbar within the MAX classification (a category for intervertebral fusion devices and spinal implants), Class II - Special Controls.

Submitted by Atlas Spine, Inc. (Jupiter, US). The FDA issued a Cleared decision on October 25, 2017 after a review of 84 days - a notably fast clearance cycle.

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: 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 Atlas Spine, Inc. devices

Submission Details

510(k) Number K172334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2017
Decision Date October 25, 2017
Days to Decision 84 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 122d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.
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 - MAX Intervertebral Fusion Device With Bone Graft, Lumbar

All 465
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K172334.
Cascadia Interbody System
K172009 · K2m, Inc. · Dec 2017
Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion System
K173153 · Nu Vasive, Incorporated · Dec 2017
NuVasive® Modulus TLIF Interbody System
K172341 · Nu Vasive, Incorporated · Oct 2017
NuVasive® Modulus XLIF Interbody System
K172123 · Nu Vasive, Incorporated · Oct 2017
ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology
K171689 · Medtronic Sofamor Danek USA, Inc. · Oct 2017
NuVasive TLX Interbody System
K171633 · Nu Vasive, Incorporated · Sep 2017