Cleared Special

K170455 - MectaLIF Anterior Stand Alone

K170455 is the FDA 510(k) clearance for MectaLIF Anterior Stand Alone by Medacta International S.A.. It is a Class 2 Orthopedic device (product code OVD) cleared through the Special 510(k) pathway after a 29-day FDA review.

K170455 · Medacta International S.A. · Orthopedic device
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Mar 2017
Decision
29d
Days
Class 2
Risk

K170455 is an FDA 510(k) clearance for the MectaLIF Anterior Stand Alone. Classified as Intervertebral Fusion Device With Integrated Fixation, Lumbar (product code OVD), Class II - Special Controls.

Submitted by Medacta International S.A. (Castel San Pietro (Ch), CH). The FDA issued a Cleared decision on March 16, 2017 after a review of 29 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 Medacta International S.A. devices

Submission Details

510(k) Number K170455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2017
Decision Date March 16, 2017
Days to Decision 29 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
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Lumbar Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation.
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

Mapi USA, Inc.
Roshana Ahmed

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 - OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

All 148
Devices cleared under the same product code (OVD) and FDA review panel - the closest regulatory comparables to K170455.
Rampart One Lumbar Interbody Fusion Device
K163670 · Spineology, Inc. · May 2017
NuVasive BASE Interfixated Titanium System
K170592 · Nu Vasive, Incorporated · Apr 2017
Ax Stand-Alone ALIF System
K162236 · Innovasis, Inc. · Apr 2017
SOVEREIGN® Spinal System
K162680 · Medtronic Sofamor Danek USA, Inc. · Dec 2016
SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device
K162351 · SeaSpine Orthopedics Corporation · Dec 2016
Leva® Anterior Interbody System
K161993 · Spine Wave, Inc. · Nov 2016