Cleared Traditional

K163364 - MOJAVE Expandable Interbody System

K163364 is the FDA 510(k) clearance for MOJAVE Expandable Interbody System by K2m. It is a Class 2 Orthopedic device (product code MAX) cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K163364 · K2m · Orthopedic device
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Mar 2017
Decision
105d
Days
Class 2
Risk

K163364 is an FDA 510(k) clearance for the MOJAVE Expandable Interbody 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 K2m (Leesburg, US). The FDA issued a Cleared decision on March 15, 2017 after a review of 105 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.

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Submission Details

510(k) Number K163364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2016
Decision Date March 15, 2017
Days to Decision 105 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
17d faster than avg
Panel avg: 122d · This submission: 105d
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 596
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K163364.
NuVasive CoRoent Ti-C System
K163707 · Nu Vasive, Incorporated · May 2017
Leva Anterior Expandable Spacer System
K163246 · Spine Wave, Inc. · Apr 2017
NuVasive Modulus XLIF Interbody System
K163230 · Nu Vasive, Incorporated · Mar 2017
Rampart(TM) T Lumbar Interbody Fusion Device
K163409 · Spineology, Inc. · Mar 2017
SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION® Spacers, COALITION AGX™ Spacers, INDEPENDENCE® Spacers, FORTIFY®-R Corpectomy Spacers, FORTIFY® I-R Corpectomy Spacers, XPand®-R Corpectomy Spacers, NIKO® Corpectomy Spacers, MONUMENT™ Spacers, ALTERA™ Spacers, MAGNIFY™ Spacers, InterContinental® Plate-Spacer
K152022 · Globus Medical, Inc. · Feb 2017
Elite Expandable Interbody Fusion Device
K162879 · Spineology, Inc. · Jan 2017