Cleared Special

Tranquil-C Interbody System (K240416) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K240416 · Nexus Spine, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2024
Decision
29d
Days
Class 2
Risk

K240416 is an FDA 510(k) clearance for the Tranquil-C Interbody System. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Nexus Spine, LLC (Salt Lake City, US). The FDA issued a Cleared decision on March 12, 2024 after a review of 29 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 Nexus Spine, LLC devices

Submission Details

510(k) Number K240416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2024
Decision Date March 12, 2024
Days to Decision 29 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
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code ODP Intervertebral Fusion Device With Bone Graft, 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.
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 - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 179
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K240416.
Spectrum Spine Cervical Cage System
K240838 · Spectrum Spine, Inc. · May 2024
uCerv Flux™-C 3D Porous Titanium Cervical Interbody
K241396 · Ulrich Medical USA, Inc. · May 2024
MATRIX HA PEEK Cervical IBF System
K232619 · Sapphire Medical Group · Mar 2024
BEE Cervical Cage
K231371 · NGMedical GmbH · Jan 2024
Peridot-PT Anterior Cervical Intervertebral body fusion System
K233839 · Gbs Commonwealth Co., Ltd. · Dec 2023
Align Cervical Interbody Fusion System
K230639 · Acuity Surgical Devices, LLC · Dec 2023