Cleared Special

K161888 - JULIET® LL Lateral Lumbar Cage

K161888 is an FDA 510(k) clearance for JULIET LL Lateral Lumbar Cage, manufactured by Spineart. The device is a Class 2 Orthopedic device with product code MAX cleared through the Special 510(k) pathway after a 63-day FDA review.

K161888 · Spineart · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
63d
Days
Class 2
Risk

K161888 is an FDA 510(k) clearance for the JULIET® LL Lateral Lumbar Cage. 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 September 12, 2016 after a review of 63 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Spineart devices

FDA 510(k) Submission Details - K161888

510(k) Number K161888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2016
Decision Date September 12, 2016
Days to Decision 63 days
Submission Type Special
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
59d faster than avg
Panel avg: 122d · This submission: 63d
Pathway characteristics
Modification to existing cleared device.

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 Peers - MAX Intervertebral Fusion Device With Bone Graft, Lumbar

All 849
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K161888.
nva, nvp, and nvt
K162426 · Nvision Biomedical Technologies, LLC · Sep 2016
Cascadia Interbody System
K162264 · K2m, Inc. · Sep 2016
PROW FUSION-L
K153665 · Nlt Spine, Ltd. · Sep 2016
Nanovis Intervertebral Body Fusion System and Forticore(R)
K161485 · Nanovis, LLC · Sep 2016
NuVasive Lumbar Interbody Implants
K161230 · Nu Vasive, Incorporated · Aug 2016
XYcor® Expandable Spinal Spacer System
K160646 · Alphatec Spine, Inc. · Aug 2016