Cleared Traditional

OIC Variable Angle Small Fragment Locking Plate System (K223118) - FDA 510(k) Clearance

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

K223118 · Orthopaedic Implant Company · Orthopedic device
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Jan 2023
Decision
110d
Days
Class 2
Risk

K223118 is an FDA 510(k) clearance for the OIC Variable Angle Small Fragment 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 Orthopaedic Implant Company (Reno, US). The FDA issued a Cleared decision on January 21, 2023 after a review of 110 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 Orthopaedic Implant Company devices

Submission Details

510(k) Number K223118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2022
Decision Date January 21, 2023
Days to Decision 110 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
12d faster than avg
Panel avg: 122d · This submission: 110d
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 699
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K223118.
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K213059 · Auxein Medical Private Limited · Jan 2023
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Anatomic Bone Plate
K221088 · Double Medical Technology, Inc. · Jan 2023
Treace Medical Concepts (TMC) Plating System
K221181 · Treace Medical Concepts, Inc. · Jan 2023
TriMed Wrist Fixation System 3
K222637 · TriMed, Inc. · Dec 2022