Cleared Traditional

K243469 - SIGNEX

K243469 is the FDA 510(k) clearance for SIGNEX by Osteonic Co., Ltd.. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K243469 · Osteonic Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
202d
Days
Class 2
Risk

K243469 is an FDA 510(k) clearance for the SIGNEX. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Osteonic Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on May 29, 2025 after a review of 202 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Osteonic Co., Ltd. devices

Submission Details

510(k) Number K243469 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2024
Decision Date May 29, 2025
Days to Decision 202 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
80d slower than avg
Panel avg: 122d · This submission: 202d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 Consultant

Wise Company, Inc.
Sanglok Lee

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HRS Plate, Fixation, Bone

All 895
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K243469.
LORRAINE 2.5/3.5mm Distal Humerus System
K250933 · Bonebridge AG · Jun 2025
Montblanc Plate System
K243368 · Medifield Medical Co., Ltd. · Jun 2025
ARIX Pectus Bar System
K242751 · Jeil Medical Corporation · May 2025
TriMed Fifth Metatarsal System (Fifth Metatarsal Plate)
K250935 · TriMed, Inc. · May 2025
Pediatric Plating Platform Hip
K243963 · OrthoPediatrics Corp. · Apr 2025
CastleLoc Pectus Bar System
K250892 · L & K Biomed Co., Ltd. · Apr 2025