Cleared Traditional

Tranquil-L Interbody System (K181702) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K181702 · Nexus Spine, LLC · Orthopedic device
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Sep 2018
Decision
86d
Days
Class 2
Risk

K181702 is an FDA 510(k) clearance for the Tranquil-L Interbody System. 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 Nexus Spine, LLC (Salt Lake City, US). The FDA issued a Cleared decision on September 21, 2018 after a review of 86 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 Nexus Spine, LLC devices

Submission Details

510(k) Number K181702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2018
Decision Date September 21, 2018
Days to Decision 86 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
36d faster than avg
Panel avg: 122d · This submission: 86d
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 464
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K181702.
NuVasive Cohere Thoracolumbar Interbody System
K181860 · Nu Vasive, Incorporated · Oct 2018
DualX
K181397 · Innovasive, Inc. · Sep 2018
Fixated Asfora BULLET CAGE® (FABC)
K181591 · Medical Designs, LLC · Sep 2018
Sypher Spacer System
K181337 · Biogennix, LLC · Sep 2018
LnK Lumbar Interbody Fusion Cage System
K181380 · L & K Biomed Co., Ltd. · Sep 2018
Renovis S180 Lateral Lumbar Interbody Fusion System
K181655 · Renovis Surgical Technologies · Sep 2018