Cleared Traditional

Aries® Lumbar Interbodies (K181347) - FDA 510(k) Clearance

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

K181347 · Osseus Fusion Systems, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2018
Decision
86d
Days
Class 2
Risk

K181347 is an FDA 510(k) clearance for the Aries® Lumbar Interbodies. 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 Osseus Fusion Systems, LLC (Dallas, US). The FDA issued a Cleared decision on August 15, 2018 after a review of 86 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 Osseus Fusion Systems, LLC devices

Submission Details

510(k) Number K181347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2018
Decision Date August 15, 2018
Days to Decision 86 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
36d faster than avg
Panel avg: 122d · This submission: 86d
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 Consultant

The OrthoMedix Group, Inc.
J. D. Webb

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MAX Intervertebral Fusion Device With Bone Graft, Lumbar

All 468
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K181347.
Renovis S180 Lateral Lumbar Interbody Fusion System
K181655 · Renovis Surgical Technologies · Sep 2018
Tranquil Interbody System
K181483 · Nexus Spine, LLC · Aug 2018
CancelleX Porous Titanium Lumbar Interbody Device
K180373 · Xenco Medical, LLC · Aug 2018
Duo™ Lumbar Interbody Fusion Device
K181792 · Spineology, Inc. · Aug 2018
TirboLOX-L Lumbar IBFD
K180990 · Captiva Spine, Inc. · Aug 2018
K2M Expandable Interbody System
K180777 · K2m, Inc. · Aug 2018