Cleared Traditional

K142504 - SpineFrontier Lumbar Interbody Fusion Device System

K142504 is an FDA 510(k) clearance for SpineFrontier Lumbar Interbody Fusion D..., manufactured by Spinefrontier, Inc.. The device is a Class 2 Orthopedic device with product code MAX cleared through the Traditional 510(k) pathway after a 250-day FDA review.

K142504 · Spinefrontier, Inc. · Orthopedic device
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May 2015
Decision
250d
Days
Class 2
Risk

K142504 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. (Beverly, US). The FDA issued a Cleared decision on May 13, 2015 after a review of 250 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. 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 Spinefrontier, Inc. devices

FDA 510(k) Submission Details - K142504

510(k) Number K142504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2014
Decision Date May 13, 2015
Days to Decision 250 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
128d slower than avg
Panel avg: 122d · This submission: 250d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MAX Device Classification - Class 2, Special Controls

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

Empirical Testing Corp
Meredith May

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 797
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K142504.
ELEVATE Spinal System
K142559 · Medtronic Sofamor Danek USA, Inc. · Jun 2015
Battalion Universal Spacer System
K143740 · Alphatec Spine, Inc. · May 2015
Lucent
K150061 · Spinal Elements, Inc. · May 2015
The Octane Straight Intervertebral Fusion Device, Ti Coated
K150152 · Exactech, Inc. · May 2015
NuVasive(R) CCX-L Interbody System
K143595 · Nu Vasive, Incorporated · Apr 2015
INTERBODY CAGE
K140348 · Eisertech, LLC · Apr 2015