# K141045: MBD Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Mbd Medical, LLC
- Decided: Jun 30, 2014 after 68 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).
- (no number) Synthes One-Third Tubular DCL Plate: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K091376: Variax Clavicle System. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The MBD Plate System is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula.

Source page: https://510kreport.com/device/K141045
Methodology: https://510kreport.com/methodology