# K071809: Ensplintrx Bone Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Sonoma Orthopedic Products, Inc.
- Decided: Feb 21, 2008 after 234 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: 6 generations back to K962616 (1996). 10 ancestors in all.
6 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)
- K994061: Locon-T Distal Radial Plate, Wrightmedicaltechnologyinc (2000) Summary page 1.
- K040938: Radial Nail System, Wrightmedicaltechnologyinc (2004) Summary page 1.
- K042437: Dorsal Intramedullary Plate, Deo Volente Orthopaedics, LLC (2004) Summary page 1.

## Most influential descendants
- 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
- K141737: Conventus PHS System (2015), 0 descendants of its own

## Indications for use
The ENSPLINTRxTM Distal Radius 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; * Osteotomy and repair of distal radius malunion with or without bone graft; * Non-displaced fractures in which the physician and patient opt for rigid stability • Transverse fractures of the distal radius with dr without comminution (e.g. AO classifications A2 and A3) * Transverse fractures of the distal radius with an extension into the joint without comminution (e.g. AO classification C 1); * Failed fracture fixation with or without bone graft for the types of fractures above; * The above types of fractures (i.e. AO classifications non-displaced transverse, A2, A3, and C1) in which reduction has been lost following fixation with percutaneous pins with or without an external fixator.

Source page: https://510kreport.com/device/K071809
Methodology: https://510kreport.com/methodology