# K042437: Dorsal Intramedullary Plate

- Pathway: 510(k) (Traditional)
- Applicant: Deo Volente Orthopaedics, LLC
- Decided: Oct 8, 2004 after 30 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 K962616 (1996). 8 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032705: Distal Radius Fracture Repair System, Hand Innovations, Inc. (2003) Summary page 1.
- K994061: Locon-T Distal Radial Plate, Wrightmedicaltechnologyinc (2000) Summary page 1.

## Most influential descendants
- K071809: Ensplintrx Bone Fixation System (2008), 6 descendants of its own
- K102689: Conventus Orthopaedics Fracture Fixation System (2013), 4 descendants of its own
- K131552: Conventus DRS (2014), 2 descendants of its own
- K151379: Conventus PRS System (2015), 1 descendant of its own
- K161048: Conventus Orthopaedics Ulna Fixation System (2016), 0 descendants of its own

## Indications for use
The fixation of fractures and osteotomies involving the distal radius. This single use device is for cementless use only.

Source page: https://510kreport.com/device/K042437
Methodology: https://510kreport.com/methodology