# K253115: Lars Acj

- Pathway: 510(k) (Traditional)
- Applicant: Movmedix S.A.S.
- Decided: Jun 10, 2026 after 259 days
- Product code: HTN (Washer, Bolt Nut)
- 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 K792022 (1979). 42 ancestors in all.
No later device cites it as a predicate yet.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190143: LARS AC Band Device, Corin USA (2019) Summary page 5.
- K091207: Surgicraft Lockdown Acromioclavicular (AC) Device, Surgicraft, Ltd. (2011) Summary page 5.

## Indications for use
The LARS® ACJ is indicated to provide fixation during the healing process following syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions. The LARS® ACJ implant components are for single use only.

Source page: https://510kreport.com/device/K253115
Methodology: https://510kreport.com/methodology