# K143323: OS2-V Varisation Staple

- Pathway: 510(k) (Traditional)
- Applicant: In2bones Sas
- Decided: Feb 26, 2015 after 99 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: 1 generation back to K991566 (1999). 2 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991566: Solustaple, New Deal, S.A. (1999) Summary page 5.
- K070033: Memometal Varisation, Models AV26-08, AV26-10, AV90-08 and AV90-10, Memometal Technologies (2007) Summary page 5.

## Most influential descendants
- K153770: OS2(R)-VP Varisation Staple (2016), 4 descendants of its own
- K233302: OSSIOfiber® Compression Staple (2023), 1 descendant of its own
- K170688: PIT’Stop® implant (2017), 1 descendant of its own
- K241932: OSSIOfiber® Compression Staple (2024), 0 descendants of its own
- K222820: BRM TOOL Screws, BIOPLAN Subtalar Implant (2022), 0 descendants of its own

## Indications for use
The OS2®-V Varisation Staples are indicated for Akin type osteotomies.

Source page: https://510kreport.com/device/K143323
Methodology: https://510kreport.com/methodology