# K262649: Alians Forearm

- Pathway: 510(k) (Traditional)
- Applicant: Newclip Technics
- Decided: Sep 28, 2026 after 60 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: 9 generations back to K962616 (1996). 35 ancestors in all.
No later device cites it as a predicate yet.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243987: TriMed Elbow and Forearm System, TriMed, Inc. (2025) Summary page 5.
- K043263: Trimed Osteotomy Plate, TriMed, Inc. (2005) Summary page 5.
- K011335: Synths One-Third Tubular DCL Plate, Synthes (Usa) (2001) Summary page 5.

## Indications for use
The implants of the Alians Forearm range are indicated for the fixation of fractures and osteotomies of the radius and the ulna.

Source page: https://510kreport.com/device/K262649
Methodology: https://510kreport.com/methodology