Cleared Special

EVOL Spinal Interbody System, EVOS Lumbar Interbody System (K180891) - FDA 510(k) Clearance

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

K180891 · Cutting Edge Spine, LLC · Orthopedic device
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May 2018
Decision
29d
Days
Class 2
Risk

K180891 is an FDA 510(k) clearance for the EVOL Spinal Interbody System, EVOS Lumbar 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 Cutting Edge Spine, LLC (Waxhaw, US). The FDA issued a Cleared decision on May 4, 2018 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 Cutting Edge Spine, LLC devices

Submission Details

510(k) Number K180891 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2018
Decision Date May 04, 2018
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 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 K180891.
STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX, ACTILIF M FLX, ACTILIF L FLX and ACTILIF Lateral-Oblique FLX
K173347 · Centinel Spine, Inc. · May 2018
NuVasive® XLX Interbody System
K173892 · Nu Vasive, Incorporated · May 2018
Hexanium® TLIF
K180437 · Spinevision, S.A.S. · May 2018
STYLO Interbody Fusion Device
K180071 · Legend Spine Technologies · May 2018
ACRON™ TLIF System
K171151 · Spinemed Ges.M.B.H · Apr 2018
UNiD Patient Specific 3D printed cage
K173782 · Medicrea International SA · Apr 2018