# K152000: SMV Scientific Bone Plate and Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Smv Scientific
- Decided: Nov 25, 2015 after 128 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: 5 generations back to K981372 (1998). 13 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092609: Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking Compression Plates (LCP), Synthes (Usa) (2009) Summary page 6.

## Most influential descendants
- K190430: OsteoCentric Bone Plate and Screw System (2019), 2 descendants of its own
- K250494: The OsteoCentric Bone Plate and Screw System (2025), 1 descendant of its own
- K251913: OsteoCentric® UnifiMI® TCS Plating System (2025), 0 descendants of its own

## Indications for use
The SMV Bone Plate and Screw System is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, including, periarticular and intraarticular fractures.

Source page: https://510kreport.com/device/K152000
Methodology: https://510kreport.com/methodology