# K153395: OS2-C Compression Staple

- Pathway: 510(k) (Traditional)
- Applicant: In2bones Sas
- Decided: Feb 18, 2016 after 86 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: 6 generations back to K915818 (1992). 46 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112794: Eos Small Bone Fixation System, TriMed, Inc. (2012) Summary page 5.
- K011716: The Uni-Clip Staple, New Deal, S.A. (2001) Summary page 5.
- K070031: Memometal Memory Staples, Memometal Technologies (2007) Summary page 5.
- K071586: Bioraptor 2.3 PK Suture Anchor, Smith & Nephew Inc., Endoscopy Division (2007) Summary page 5.

## Most influential descendants
- K163440: Stealth Staple System (2017), 3 descendants of its own
- K212594: OSSIOfiber® Staple (2022), 2 descendants of its own
- K233302: OSSIOfiber® Compression Staple (2023), 1 descendant of its own
- K220181: StealthFix Intraosseous Fixation System (2022), 1 descendant of its own
- K241932: OSSIOfiber® Compression Staple (2024), 0 descendants of its own

## Indications for use
The OS2®-C Compression Staples are indicated for fixation of arthrodesis, osteotomies and fractures in hand or foot surgery. The number and size of the OS2®-C Compression Staples must be adapted to the indication.

Source page: https://510kreport.com/device/K153395
Methodology: https://510kreport.com/methodology