Cleared Special

K181829 - Velofix TLIF Cage

K181829 is the FDA 510(k) clearance for Velofix TLIF Cage by U&I Corporation. It is a Class 2 Orthopedic device (product code MAX) cleared through the Special 510(k) pathway after a 128-day FDA review.

K181829 · U&I Corporation · Orthopedic device
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Nov 2018
Decision
128d
Days
Class 2
Risk

K181829 is an FDA 510(k) clearance for the Velofix TLIF Cage. 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 U&I Corporation (Uijeongbu-Si, KR). The FDA issued a Cleared decision on November 14, 2018 after a review of 128 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all U&I Corporation devices

Submission Details

510(k) Number K181829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2018
Decision Date November 14, 2018
Days to Decision 128 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
6d slower than avg
Panel avg: 122d · This submission: 128d
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 603
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K181829.
MectaLIF Posterior Extension
K181970 · Medacta International S.A. · Dec 2018
ATEC ALIF and LLIF Spacer System
K182746 · Alphatec Spine, Inc. · Nov 2018
Plateau Spacer System
K182470 · Life Spine · Nov 2018
ostaPek Interbody Fusion Cages
K181963 · Coligne AG · Nov 2018
Spinal Elements Ti-Bond coated devices
K181837 · Spinal Elements, Inc. · Nov 2018
Duo Lumbar Interbody Fusion Device
K182322 · Spineology, Inc. · Oct 2018