# K170310: Alians Clavicle range

- Pathway: 510(k) (Traditional)
- Applicant: Newclip Technics
- Decided: Mar 30, 2017 after 57 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). 33 ancestors in all.
No later device cites it as a predicate yet.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100944: Clavicle Locking Plate System, Newclip Technics (2010) Summary page 5.
- K102998: Congruent Bone Plate  System, Acumed, LLC (2011) Summary page 5.

## Indications for use
The implants of the Alians Clavicle range are dedicated to the fixation of fractures, mal-unions, non-unions and osteotomies of the clavicle in adults.

Source page: https://510kreport.com/device/K170310
Methodology: https://510kreport.com/methodology