# K261145: Avanti Distal Elbow ORIF System

- Pathway: 510(k) (Abbreviated)
- Applicant: Avanti Orthopaedics, LLC
- Decided: May 9, 2026 after 32 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: 13 generations back to K841189 (1984). 265 ancestors in all.
No later device cites it as a predicate yet.
0 of 266 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120717: Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal Humerus Plates), Synthes USA (2012) Summary page 5.
- K240613: APTUS Elbow Dorsal Olecranon Plates, Medartis AG (2024) Summary page 5.
- K983988: Syntec-Taichung Non-Sterile Titanium Alloy Mini-Plate, Syntec Scientific Corp. (1999) Summary page 5.
- K222967: Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws, Avanti Orthopaedics, Inc. (2022) Summary page 5.
- K211592: Avanti Orthopaedics Ulnar Shortening System, Avanti Orthopaedics, Inc. (2021) Summary page 5.
- K191118: Avanti Distal Radius and Forearm System, Avanti Orthopaedics, Inc. (2019) Summary page 5.

## Indications for use
The Distal Elbow ORIF System is intended for fixation of fractures of the olecranon, radius, and ulna in adults. Specifically, • Olecranon plates are indicated for fixation of fractures and osteotomies, malunions and non-unions of the olecranon and proximal ulna. • Straight and curved forearm plates are indicated for fixation of fractures and osteotomies of the radius and ulna.

Source page: https://510kreport.com/device/K261145
Methodology: https://510kreport.com/methodology