Cleared Special

K160547 - Cascadia Interbody System (FDA 510(k) Clearance)

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

K160547 · K2m · Orthopedic device
Mar 2016
Decision
27d
Days
Class 2
Risk

K160547 is an FDA 510(k) clearance for the Cascadia 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 K2m (Leesburg, US). The FDA issued a Cleared decision on March 24, 2016 after a review of 27 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.

Submission Details

510(k) Number K160547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2016
Decision Date March 24, 2016
Days to Decision 27 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 116d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 98
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K160547.
SWINGO-3D Lumbar Cage System
K254017 · Implanet · Feb 2026
LUX Expandable Lumbar Interbody System
K253583 · Xenix Medical · Feb 2026
Luna® Ti Interbody Fusion System
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Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System
K253748 · Life Spine, Inc. · Jan 2026
Titanium Interbody System
K253266 · Spine Innovation, LLC · Jan 2026
IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)
K253577 · Medicrea International S.A.S. (Medtronic) · Dec 2025