# K151160: Arcus Staple System

- Pathway: 510(k) (Traditional)
- Applicant: Nextremity Solutions, Inc.
- Decided: Sep 4, 2015 after 126 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: 4 generations back to K961522 (1996). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121277: Z-Snap Off Screw, Z-Double Thread Compression Screw, Z-Guide Wire, Z-Staple, Z-Medical GmbH & Co. KG (2012) Summary page 4.
- K070033: Memometal Varisation, Models AV26-08, AV26-10, AV90-08 and AV90-10, Memometal Technologies (2007) Summary page 4.

## Most influential descendants
- K210456: Ligament Staple (2021), 0 descendants of its own

## Indications for use
The Nextremity Solutions Arcus™ Staple System is indicated for fixation of bone fractures, bone reconstruction, ligament, soft tissue and tendon. Examples include: · Fixation of bone fragments or small bones fractures · Fracture management in the foot and hand

Source page: https://510kreport.com/device/K151160
Methodology: https://510kreport.com/methodology