Cleared Special

K171097 - MOJAVE Expandable Interbody System

K171097 is the FDA 510(k) clearance for MOJAVE Expandable Interbody System by K2m, Inc.. It is a Class 2 Orthopedic device (product code MAX) cleared through the Special 510(k) pathway after a 27-day FDA review.

K171097 · K2m, Inc. · Orthopedic device
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May 2017
Decision
27d
Days
Class 2
Risk

K171097 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, Inc. (Leesburg, US). The FDA issued a Cleared decision on May 10, 2017 after a review of 27 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all K2m, Inc. devices

Submission Details

510(k) Number K171097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2017
Decision Date May 10, 2017
Days to Decision 27 days
Submission Type Special
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
95d faster than avg
Panel avg: 122d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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

K2m
Nancy Giezen

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 603
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K171097.
NuVasive® CoRoent® Thoracolumbar System
K170962 · Nu Vasive, Incorporated · Jun 2017
FUSE Spinal System
K171468 · Medtronic Sofamor Danek · Jun 2017
DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM
K162212 · Medtronic Sofamor Danek USA, Inc. · May 2017
NuVasive CoRoent Ti-C System
K163707 · Nu Vasive, Incorporated · May 2017
Leva Anterior Expandable Spacer System
K163246 · Spine Wave, Inc. · Apr 2017
LOSPA IS TLIF & DLIF Cages
K170243 · Corentec Co., Ltd. · Mar 2017