# K040938: Radial Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Jul 1, 2004 after 80 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.
9 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) LOCON-T® Distal Radial Plating System: named in the summary without a submission number

## 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
- K150073: MICRONAIL  Distal Radius System (2015), 1 descendant of its own

## Indications for use
The Radial Nail System is intended to be used for the fixation of unstable distal radius fractures in which closed reduction is not suitable: * Joint destruction and/or subluxation visible on x-ray; * Failed fracture fixation with or without bone graft; * Osteotomy and repair of distal radius malunion with or without bone graft; * Displaced or non-displaced fracture which may or may not involve angulation or fragmentation of bone; * Comminuted articular fractures, shearing fractures of the articular surface, severely comminuted extra-articular fractures, and fractures in which reduction has been lost following fixation with percutaneous pins with or without an external fixator.

Source page: https://510kreport.com/device/K040938
Methodology: https://510kreport.com/methodology