# K200361: Akros Scruture Anchor LisFranc Repair Kit

- Pathway: 510(k) (Traditional)
- Applicant: Akros Medical
- Decided: Apr 6, 2020 after 52 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: 8 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)
- K061925: Mini Tightrope Repair Kit, Model AR-8911DS, Arthrex, Inc. (2006) Summary page 4.

## Indications for use
The Akros Scruture Anchor LisFranc Repair Kit is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external fixation systems involving plates, with fracture braces and casting. Specifically, the Akros Scruture Anchor LisFranc Repair Kit is intended to provide fixation during the healing process following Tarasometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction).

Source page: https://510kreport.com/device/K200361
Methodology: https://510kreport.com/methodology