Cleared Traditional

K231251 - FlexWing Anterior Cervical Plate System

K231251 is the FDA 510(k) clearance for FlexWing Anterior Cervical Plate System by Jeil Medical Corporation. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 450-day FDA review.

K231251 · Jeil Medical Corporation · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2024
Decision
450d
Days
Class 2
Risk

K231251 is an FDA 510(k) clearance for the FlexWing Anterior Cervical Plate System. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Jeil Medical Corporation (Seoul, KR). The FDA issued a Cleared decision on July 24, 2024 after a review of 450 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Jeil Medical Corporation devices

Submission Details

510(k) Number K231251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2023
Decision Date July 24, 2024
Days to Decision 450 days
Submission Type Traditional
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
328d slower than avg
Panel avg: 122d · This submission: 450d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 421
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K231251.
Cervical Plating System
K243369 · Life Spine, Inc. · Dec 2024
OZARK Cervical Plate System
K242361 · Stryker Spine · Nov 2024
Skyway Anterior Cervical Plate System
K243015 · Kyocera Medical Technologies, Inc. · Nov 2024
Wolff's Law Anterior Cervical Plate System
K240592 · Spinal Simplicity, LLC · May 2024
icotec Anterior Cervical Plate System
K233215 · Icotec AG · May 2024
ARENAL Anterior Cervical Plate System
K240935 · Effortmed, LLC · May 2024