Cleared Traditional

K190877 - Juliet Ti LL Lumbar Interbody Device

K190877 is the FDA 510(k) clearance for Juliet Ti LL Lumbar Interbody Device by Spineart. It is a Class 2 Orthopedic device (product code OVD) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K190877 · Spineart · Orthopedic device
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May 2019
Decision
55d
Days
Class 2
Risk

K190877 is an FDA 510(k) clearance for the Juliet® Ti LL Lumbar Interbody Device. Classified as Intervertebral Fusion Device With Integrated Fixation, Lumbar (product code OVD), Class II - Special Controls.

Submitted by Spineart (Plan Les Ouates, CH). The FDA issued a Cleared decision on May 29, 2019 after a review of 55 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 devices

Submission Details

510(k) Number K190877 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2019
Decision Date May 29, 2019
Days to Decision 55 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
67d faster than avg
Panel avg: 122d · This submission: 55d
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 Peers - OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

All 147
Devices cleared under the same product code (OVD) and FDA review panel - the closest regulatory comparables to K190877.
Rampart™ One Lumbar Interbody Fusion System
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K191263 · Clariance, Sas · Jun 2019
Rampart One Lumbar Interbody Fusion System
K191091 · Spineology, Inc. · May 2019
MectaLIF Anterior Stand Alone Extension
K183426 · Medacta International S.A. · Mar 2019
Avenue P Cage System
K181096 · Zimmer Biomet Spine, Inc. · Jan 2019