Cleared Traditional

K172484 - A-CIFT SoloFuse

K172484 is the FDA 510(k) clearance for A-CIFT SoloFuse by Spinefrontier, Inc.. It is a Class 2 Orthopedic device (product code OVE) cleared through the Traditional 510(k) pathway after a 264-day FDA review.

K172484 · Spinefrontier, Inc. · Orthopedic device
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May 2018
Decision
264d
Days
Class 2
Risk

K172484 is an FDA 510(k) clearance for the A-CIFT SoloFuse. Classified as Intervertebral Fusion Device With Integrated Fixation, Cervical (product code OVE), Class II - Special Controls.

Submitted by Spinefrontier, Inc. (Malden, US). The FDA issued a Cleared decision on May 8, 2018 after a review of 264 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

Submission Details

510(k) Number K172484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2017
Decision Date May 08, 2018
Days to Decision 264 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
142d slower than avg
Panel avg: 122d · This submission: 264d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Cervical 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

Empirical Testing Corp
Meredith L. 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 - OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

All 110
Devices cleared under the same product code (OVE) and FDA review panel - the closest regulatory comparables to K172484.
MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate
K182151 · Ctl Medical Corporation · Oct 2018
Genesys Spine AIS-C Cervical Stand-Alone System
K181295 · Genesys Spine · Aug 2018
Pro-Link® Ti Stand-Alone Cervical Spacer System
K180642 · Life Spine, Inc. · May 2018
Genesys Spine AIS-C Cervical Anchored Interbody System
K180056 · Genesys Spine · Mar 2018
Cavetto-SA Cervical Cage System
K173077 · Neurostructures, Inc. · Feb 2018
Paramount Anterior Cervical Cage System
K173175 · Spine Wave, Inc. · Nov 2017