Cleared Traditional

Ali Interbody Fusion System (K191516) - FDA 510(k) Clearance

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

K191516 · Raed M. Ali, M.D., Inc. · Orthopedic device
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Sep 2019
Decision
97d
Days
Class 2
Risk

K191516 is an FDA 510(k) clearance for the Ali 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 Raed M. Ali, M.D., Inc. (Newport Coast, US). The FDA issued a Cleared decision on September 12, 2019 after a review of 97 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 Raed M. Ali, M.D., Inc. devices

Submission Details

510(k) Number K191516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2019
Decision Date September 12, 2019
Days to Decision 97 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
25d faster than avg
Panel avg: 122d · This submission: 97d
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

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Kristen Allen

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 464
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K191516.
HEDRON Lumbar Spacers
K191391 · Globus Medical, Inc. · Sep 2019
AccelFix Lumbar Interbody Fusion Cage System
K190708 · L & K Biomed Co., Ltd. · Sep 2019
Republic Spine Restore Intervertebral Body Fusion System
K190398 · Republic Spine, LLC · Sep 2019
Triton Cage
K183407 · Medyssey USA, Inc. · Aug 2019
Zavation eZspand Interbody System
K191339 · Zavation Medical Products, LLC · Aug 2019
ATEC Lateral Interbody System
K191311 · Alphatec Spine, Inc. · Aug 2019