Cleared Special

K193106 - SpineFrontier Lumbar Interbody Fusion D...

K193106 is the FDA 510(k) clearance for SpineFrontier Lumbar Interbody Fusion D... by Spinefrontier, Inc.. It is a Class 2 Orthopedic device (product code MAX) cleared through the Special 510(k) pathway after a 224-day FDA review.

K193106 · Spinefrontier, Inc. · Orthopedic device
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Jun 2020
Decision
224d
Days
Class 2
Risk

K193106 is an FDA 510(k) clearance for the SpineFrontier Lumbar Interbody Fusion Device 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 Spinefrontier, Inc. (Malden, US). The FDA issued a Cleared decision on June 19, 2020 after a review of 224 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Spinefrontier, Inc. devices

Submission Details

510(k) Number K193106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2019
Decision Date June 19, 2020
Days to Decision 224 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
102d slower than avg
Panel avg: 122d · This submission: 224d
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 Peers - MAX Intervertebral Fusion Device With Bone Graft, Lumbar

All 576
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