# K210456: Ligament Staple

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Apr 12, 2021 after 55 days
- Product code: JDR (Staple, 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: 5 generations back to K961522 (1996). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151160: Arcus Staple System, Nextremity Solutions, Inc. (2015) Summary page 4.

## Indications for use
The Medacta Ligament Staple is intended for use in medial collateral ligament (MCL) and lateral collateral ligament (LCL) reconstruction. Reconstructive treatment of ruptured or damaged MCL and LCL.

Source page: https://510kreport.com/device/K210456
Methodology: https://510kreport.com/methodology