# K172786: MDS Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Miami Device Solutions, LLC
- Decided: Dec 8, 2017 after 84 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 K792022 (1979). 175 ancestors in all.
No later device cites it as a predicate yet.
0 of 176 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143394: Acumed Small Fragment Base Set, Acumed, LLC (2015) Summary page 4.
- K161292: Distal Radius Plating System, Miami Device Solutions, LLC (2016) Summary page 4.
- K162635: Distal Radius Plating System, Miami Device Solutions, LLC (2016) Summary page 4.
- K162898: Olecranon Plating System, Miami Device Solutions, LLC (2017) Summary page 4.
- K141493: Proximal Humerus Plating System, Miami Device Solutions (2015) Summary page 5.
- K992891: Synthes Cerclage Positioning Pin, Synthes (Usa) (1999) Summary page 5.
- K132502: Variax 2 System, Stryker Trauma AG (2013) Summary page 5.
- K140769: Variax 2 System, Stryker Trauma AG (2014) Summary page 5.

## Indications for use
The MDS Plating System is intended for internal fixation of fractures of various bones such as the clavicle, olecranon, humerus, radius, ulna, distal tibia, and fibula and for use in fixation of periprosthetic fractures. The system can be used with commercially available cerclage cable of material compatible with system implants including titanium alloy and cobalt chromium. The Low Profile Head Screw is used independently and is intended for internal fixation of fractures of the clavicle, olecranon, humerus, radius, ulna, distal tibia, fibula as well as foot and ankle.

Source page: https://510kreport.com/device/K172786
Methodology: https://510kreport.com/methodology