Cleared Special

K190053 - SECULOK™ ACP System

K190053 is an FDA 510(k) clearance for SECULOK 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 21-day FDA review.

K190053 · U&I Corporation · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2019
Decision
21d
Days
Class 2
Risk

K190053 is an FDA 510(k) clearance for the SECULOK™ 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 1, 2019 after a review of 21 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 - K190053

510(k) Number K190053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2019
Decision Date February 01, 2019
Days to Decision 21 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
101d faster than avg
Panel avg: 122d · This submission: 21d
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 K190053.
SMG Anterior Cervical Plate System
K183073 · Sapphire Medical Group · Feb 2019
Athena II Cervical Plate System
K183409 · Medyssey USA, Inc. · Feb 2019
Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™ Anterior Cervical Plate, Venture™ Anterior Cervical Plate, Zephir™ Anterior Cervical Plate System and Zevo™ Anterior Cervical Plate System
K182885 · Medtronic Sofamor Danek USA, Inc. · Feb 2019
Pinehurst Anterior Cervical Plate System
K181190 · Signature Orthopaedics Pty, Ltd. · Jan 2019
CervAlign™ Anterior Cervical Plate System
K183060 · Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · Jan 2019
4CIS® Pinehurst Anterior Cervical Plate system
K182489 · Solco Biomedical Co., Ltd. · Jan 2019
K190053 · SECULOK™ ACP System
Download PDF FDA Summary U&I Corporation