Cleared Special

OsteoCentric® UnifiMI® TCS Plating System (K251913) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K251913 · OsteoCentric Technologies · Orthopedic device
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Aug 2025
Decision
54d
Days
Class 2
Risk

K251913 is an FDA 510(k) clearance for the OsteoCentric® UnifiMI® TCS Plating 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 OsteoCentric Technologies (Logan, US). The FDA issued a Cleared decision on August 16, 2025 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all OsteoCentric Technologies devices

Submission Details

510(k) Number K251913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2025
Decision Date August 16, 2025
Days to Decision 54 days
Submission Type Special
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
68d faster than avg
Panel avg: 122d · This submission: 54d
Pathway characteristics
Modification to existing cleared device.

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 697
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K251913.
The Acumed Wrist Fixation System - 2.4mm Screws
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KLS Martin Ixos System
K250620 · KLS-Martin L.P. · Aug 2025
Tyber Medical Distal Radius Plating System
K251361 · Tyber Medical, LLC · Jul 2025
A.L.P.S. Proximal Humerus Plating System
K251620 · Zimmer Biomet · Jul 2025