Cleared Special

K220147 - Aspiron S ACP System

K220147 is an FDA 510(k) clearance for Aspiron S ACP System, manufactured by U&I Corporation. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Special 510(k) pathway after a 28-day FDA review.

K220147 · U&I Corporation · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2022
Decision
28d
Days
Class 2
Risk

K220147 is an FDA 510(k) clearance for the Aspiron S ACP System. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by U&I Corporation (Uijeongbu-Si, KR). The FDA issued a Cleared decision on February 16, 2022 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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.

FDA 510(k) Submission Details - K220147

510(k) Number K220147 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2022
Decision Date February 16, 2022
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

KWQ Device Classification - Class 2, Special Controls

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 667
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K220147.
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K211712 · Orthofix US, LLC · Feb 2022
Cyclops™ Anterior Cervical Plate System
K213901 · Degen Medical · Jan 2022
Vy Spine™ VyWasher™ Buttress System
K213219 · Vy Spine, LLC · Dec 2021
K220147 · Aspiron S ACP System
Download PDF FDA Summary U&I Corporation