Cleared Traditional

K141825 - IDEAL Locking Plate System

K141825 is an FDA 510(k) clearance for IDEAL Locking Plate System, manufactured by Jiangsu Ideal Medical Science & Technology Co., LT. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 239-day FDA review.

K141825 · Jiangsu Ideal Medical Science & Technology Co., LT · Orthopedic device
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Mar 2015
Decision
239d
Days
Class 2
Risk

K141825 is an FDA 510(k) clearance for the IDEAL Locking Plate System. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Jiangsu Ideal Medical Science & Technology Co., LT (Shanghai, CN). The FDA issued a Cleared decision on March 3, 2015 after a review of 239 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 Jiangsu Ideal Medical Science & Technology Co., LT devices

FDA 510(k) Submission Details - K141825

510(k) Number K141825 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2014
Decision Date March 03, 2015
Days to Decision 239 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
117d slower than avg
Panel avg: 122d · This submission: 239d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

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 Peers - HRS Plate, Fixation, Bone

All 1046
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K141825.
Tarsa-Link Wedge Fixation System
K150368 · Life Spine · Mar 2015
Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)
K150099 · Synthes USA Products, LLC · Mar 2015
Zimmer Plates and Screws System (ZPS) - Non-sterile ZPS
K143331 · Zimmer, Inc. · Mar 2015
Biomet Microfixation Thoracic Fixation System
K142823 · Biomet Microfixation · Feb 2015
Zimmer Periarticular Plating System
K150121 · Zimmer, Inc. · Feb 2015
HIGH TIBIAL OSTEOTOMY SYSTEM
K141548 · Newclip Technics · Jan 2015