# K251913: OsteoCentric® UnifiMI® TCS Plating System

- Pathway: 510(k) (Special)
- Applicant: OsteoCentric Technologies
- Decided: Aug 16, 2025 after 54 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K962616 (1996). 150 ancestors in all.
No later device cites it as a predicate yet.
0 of 151 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190430: OsteoCentric Bone Plate and Screw System, Osteocentric Trauma (2019)
- K140814: Evos Mini-Fragment Plating System, Smith & Nephew, Inc. (2014)
- K250494: The OsteoCentric Bone Plate and Screw System, OsteoCentric Technologies (2025) Summary page 5.

## Indications for use
The OsteoCentric® UnifiMl® TCS Plating System is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, including but not limited to periarticular and intraarticular fractures.

Source page: https://510kreport.com/device/K251913
Methodology: https://510kreport.com/methodology