# K162391: AlignMATE™ Lapidus Arthrodesis System

- Pathway: 510(k) (Special)
- Applicant: Arthrosurface, Inc.
- Decided: Feb 21, 2017 after 179 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: 11 generations back to K962616 (1996). 114 ancestors in all.
No later device cites it as a predicate yet.
0 of 115 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140617: Pinit Small Bone Fusion System, Arthrosurface, Inc. (2014) Summary page 5.
- K113762: Checkmate Metatarso-Phalangeal (MTP) Arthrodesis System, Arthrosurface, Inc. (2012) Summary page 5.

## Indications for use
Intended for the treatment of fracture fixation, osteotomies (ex. Akin, Chevron, Scarf, Weil), reconstruction, revision surgery and arthrodesis of small bones in the upper and lower extremities.

Source page: https://510kreport.com/device/K162391
Methodology: https://510kreport.com/methodology