Cleared Traditional

K240699 - SCARLET AC-Ti

K240699 is an FDA 510(k) clearance for SCARLET AC-Ti, manufactured by Spineart SA. The device is a Class 2 Orthopedic device with product code OVE cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K240699 · Spineart SA · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2024
Decision
57d
Days
Class 2
Risk

K240699 is an FDA 510(k) clearance for the SCARLET® AC-Ti. Classified as Intervertebral Fusion Device With Integrated Fixation, Cervical (product code OVE), Class II - Special Controls.

Submitted by Spineart SA (Plan-Les-Ouates, CH). The FDA issued a Cleared decision on May 10, 2024 after a review of 57 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Spineart SA devices

FDA 510(k) Submission Details - K240699

510(k) Number K240699 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2024
Decision Date May 10, 2024
Days to Decision 57 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
65d faster than avg
Panel avg: 122d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OVE Device Classification - Class 2, Special Controls

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 Peers - OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

All 124
Devices cleared under the same product code (OVE) and FDA review panel - the closest regulatory comparables to K240699.
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Genesys Spine 3DP AIS-C II Cervical Interbody System
K233594 · Genesys Spine · Dec 2023