# K153770: OS2(R)-VP Varisation Staple

- Pathway: 510(k) (Traditional)
- Applicant: In2bones Sas
- Decided: Mar 21, 2016 after 82 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: 3 generations back to K902307 (1990). 10 ancestors in all.
4 later devices descend from it; 2 cite 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)
- K143323: OS2-V Varisation Staple, In2bones Sas (2015) Summary page 5.
- K070031: Memometal Memory Staples, Memometal Technologies (2007) Summary page 5.
- K022599: Newdeal K Wire, New Deal, S.A. (2002) Summary page 5.

## Most influential descendants
- 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®-VP Varisation Staples are indicated for Akin type osteotomies.

Source page: https://510kreport.com/device/K153770
Methodology: https://510kreport.com/methodology