Cleared Traditional

Internal Locking Plate and Screw Fixation System (K232394) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K232394 · Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. · Orthopedic device
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Dec 2023
Decision
128d
Days
Class 2
Risk

K232394 is an FDA 510(k) clearance for the Internal Locking Plate and Screw Fixation 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 Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. (Changzhou, CN). The FDA issued a Cleared decision on December 15, 2023 after a review of 128 days - within the typical 510(k) review window.

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 Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. devices

Submission Details

510(k) Number K232394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2023
Decision Date December 15, 2023
Days to Decision 128 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
6d slower than avg
Panel avg: 122d · This submission: 128d
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 Peers - HRS Plate, Fixation, Bone

All 698
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K232394.
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K232652 · Tyber Medical, LLC · Dec 2023
Valkyrie Thoracic Fixation System
K232515 · Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices · Dec 2023