# K261191: Alians Elbow S

- Pathway: 510(k) (Traditional)
- Applicant: Newclip Technics
- Decided: Jul 8, 2026 after 86 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: 15 generations back to K962616 (1996). 104 ancestors in all.
No later device cites it as a predicate yet.
0 of 105 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152289: Alians Elbow Locking Plating System, Newclip Technics (2016) Summary page 5.

## Indications for use
The implants of the Alians Elbow range are dedicated to the fixation of fractures and osteotomies of the distal humerus and proximal ulna in adults.

Source page: https://510kreport.com/device/K261191
Methodology: https://510kreport.com/methodology