# K230724: arcad® 2.0 Duo & Quadro osteosynthesis compressive staples

- Pathway: 510(k) (Traditional)
- Applicant: Novastep
- Decided: Dec 4, 2023 after 263 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 K902307 (1990). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142111: Arcad Compressive Osteosynthesis Staple, Express Compressive Osteosynthesis Staple, Novatsep (2014) Summary page 5.

## Indications for use
arcad® Duo & Quadro osteosynthesis compressive staples are indicated for foot bone fragments osteotomy fixation and joint arthrodesis.

Source page: https://510kreport.com/device/K230724
Methodology: https://510kreport.com/methodology