Cleared Traditional

NEXXT MATRIXX Stand Alone ALIF System (K202230) - FDA 510(k) Clearance

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

K202230 · Nexxt Spine, LLC · Orthopedic device
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Dec 2020
Decision
130d
Days
Class 2
Risk

K202230 is an FDA 510(k) clearance for the NEXXT MATRIXX Stand Alone ALIF System. Classified as Intervertebral Fusion Device With Integrated Fixation, Lumbar (product code OVD), Class II - Special Controls.

Submitted by Nexxt Spine, LLC (Noblesville, US). The FDA issued a Cleared decision on December 15, 2020 after a review of 130 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 Nexxt Spine, LLC devices

Submission Details

510(k) Number K202230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2020
Decision Date December 15, 2020
Days to Decision 130 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
8d slower than avg
Panel avg: 122d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

Backroads Consulting
Karen E Warden

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.

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