Cleared Traditional

K160125 - Cascadia Interbody System

K160125 is the FDA 510(k) clearance for Cascadia Interbody System by K2m. It is a Class 2 Orthopedic device (product code ODP) cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K160125 · K2m · Orthopedic device
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Apr 2016
Decision
93d
Days
Class 2
Risk

K160125 is an FDA 510(k) clearance for the Cascadia Interbody System. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by K2m (Leesburg, US). The FDA issued a Cleared decision on April 22, 2016 after a review of 93 days - within the typical 510(k) review window.

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 K160125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2016
Decision Date April 22, 2016
Days to Decision 93 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 122d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 216
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K160125.
The Small PLATEAU (PLATEAU-C) Spacer System
K161127 · Life Spine, Inc. · Dec 2016
NuVasive CoRoent Small Ti-C System
K162138 · Nu Vasive, Incorporated · Oct 2016
Ascential IBD PEEKc Spacer
K161407 · Stryker Spine · Jul 2016
ANATOMIC PEEK PTC Cervical Fusion System
K160528 · Medtronic Sofamor Danek USA, Inc. · Mar 2016
PERIMETER C (Titanium) Spinal System
K153438 · Medtronic Sofamor Danek USA, Inc. · Mar 2016
CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical Interbody Device
K153373 · Medtronic Sofamor Danek · Jan 2016