# K250494: The OsteoCentric Bone Plate and Screw System

- Pathway: 510(k) (Special)
- Applicant: OsteoCentric Technologies
- Decided: Mar 18, 2025 after 26 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: 12 generations back to K962616 (1996). 95 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 97 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) Summary page 5.
- K152000: SMV Scientific Bone Plate and Screw System, Smv Scientific (2015) Summary page 5.
- K210192: A.L.P.S. Clavicle Plating System, Biomet, Inc. (2021)
- K150981: SMV Scientific Bone Screws, Smv Scientific (2015)
- K112583: Synthes Cortical Screws, Synthes (USA) Products, LLC (2011) Summary page 5.

## Most influential descendants
- K251913: OsteoCentric® UnifiMI® TCS Plating System (2025), 0 descendants of its own

## Indications for use
The OsteoCentric Bone Plate and Screw 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/K250494
Methodology: https://510kreport.com/methodology