Cleared Traditional

MONET™ Anterior Cervical Interbody Fusion Cage System (K172788) - FDA 510(k) Clearance

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

K172788 · Ctl Medical Corporation · Orthopedic device
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Jun 2018
Decision
283d
Days
Class 2
Risk

K172788 is an FDA 510(k) clearance for the MONET™ Anterior Cervical Interbody Fusion Cage System. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Ctl Medical Corporation (Addison, US). The FDA issued a Cleared decision on June 25, 2018 after a review of 283 days - an extended review 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: 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 Ctl Medical Corporation devices

Submission Details

510(k) Number K172788 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2017
Decision Date June 25, 2018
Days to Decision 283 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
161d slower than avg
Panel avg: 122d · This submission: 283d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ODP Intervertebral Fusion Device With Bone Graft, Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Cervical 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

RQMIS, Inc.
Michael A. Patz

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 - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 182
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K172788.
Curiteva Cervical Interbody Fusion System
K181261 · Curiteva, LLC · Jul 2018
Tyber Medical PT Interbody Spacer System
K180590 · Tyber Medical, LLC · Jul 2018
HD LifeSciences Cervical IBFD System
K180364 · Hd Lifesciences, LLC · Jun 2018
EVOL® ha-C Cervical Interbody Fusion System
K180674 · Cutting Edge Spine, LLC · Jun 2018
TiWAVE-C™ Porous Titanium Cervical Cage
K180401 · Kalitec Direct, LLC · Jun 2018
Atlas Spine Expandable Cervical Interbody System
K180675 · Atlas Spine, Inc. · Jun 2018