# K161048: Conventus Orthopaedics Ulna Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Conventus Orthopaedics, Inc.
- Decided: Jul 26, 2016 after 103 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: 10 generations back to K962616 (1996). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000684: Small Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 5.
- K073402: Synthes Olecranon Osteotomy Nailing System, Synthes (Usa) (2008) Summary page 5.
- K102689: Conventus Orthopaedics Fracture Fixation System, Conventus Orthopaedics (2013) Summary page 5.
- K131552: Conventus DRS, Conventus Orthopaedics (2014) Summary page 5.
- K151379: Conventus PRS System, Conventus Orthopaedics, Inc. (2015) Summary page 5.

## Indications for use
The Conventus Orthopaedics Ulna Fixation System is indicated for treatment of distal or proximal ulna fractures when internal fixation is desired, and fracture fragments are not too numerous and/or too small to be stabilized with the use of the device.

Source page: https://510kreport.com/device/K161048
Methodology: https://510kreport.com/methodology