Cleared Traditional

K153621 - Juliet Ti

K153621 is the FDA 510(k) clearance for Juliet Ti by Spineart. It is a Class 2 Orthopedic device (product code MAX) cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K153621 · Spineart · Orthopedic device
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Jul 2016
Decision
210d
Days
Class 2
Risk

K153621 is an FDA 510(k) clearance for the Juliet® Ti. 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 Spineart (Geneva, CH). The FDA issued a Cleared decision on July 15, 2016 after a review of 210 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.

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Submission Details

510(k) Number K153621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2015
Decision Date July 15, 2016
Days to Decision 210 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
88d slower than avg
Panel avg: 122d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 609
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K153621.
XYcor® Expandable Spinal Spacer System
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Tritanium® PL Cage
K160955 · Stryker · Jul 2016
Genesys Spine Apache® Lateral Lumbar Interbody Fusion System
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Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device, Rampart A lumbar Interbody Fusion Device
K160906 · Spineology, Inc. · Jul 2016
MLX™ - Medial Lateral Expandable Lumbar Interbody System
K153105 · Nu Vasive, Incorporated · Jul 2016
AccuLIF TL and PL Cage
K160715 · Stryker Corporation · Jul 2016