# K191118: Avanti Distal Radius and Forearm System

- Pathway: 510(k) (Traditional)
- Applicant: Avanti Orthopaedics, Inc.
- Decided: Dec 13, 2019 after 231 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 K841189 (1984). 93 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 95 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132704: Distal Radius Volar Rim Plate Standard, Distal Radius Volar Rim Plate Narrow, Biomet (2013) Summary page 4.
- K042355: Synthes (Usa) LCP Wrist Fusion Plates, Synthes (Usa) (2004) Summary page 4.
- K951304: Synthes 2.7 MM Cannulated Screw and Threaded Washer, Synthes (Usa) (1995) Summary page 4.
- K000684: Small Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 4.
- K160995: NEOVIEW Plating System, In2bones Sas (2016) Summary page 4.

## Most influential descendants
- K261145: Avanti Distal Elbow ORIF System (2026), 0 descendants of its own

## Indications for use
The system intended for fixation of fractures, osteotomies, malunions, and non-unions, involving the radius, ulna, and carpals. Additionally, the wrist fusion plates may be used for wrist arthrodesis.

Source page: https://510kreport.com/device/K191118
Methodology: https://510kreport.com/methodology