# K161587: Memodyn Staple

- Pathway: 510(k) (Special)
- Applicant: Austin & Associates, Inc./Telos Medical Equipment
- Decided: Feb 1, 2017 after 238 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 K002695 (2001). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002695: Memodyn Staple, Telos Medical Equipment (2001) Summary page 4.

## Most influential descendants
- K173693: Orbitum Bone Staple Implant, X and VI (2018), 0 descendants of its own
- K172205: ExoToe Staple (2018), 0 descendants of its own

## Indications for use
Memodyn Staple is intended for use in bone fixation on osteotomies, arthrodesis and fractures of the small bones of the foot, ankle and hand.

Source page: https://510kreport.com/device/K161587
Methodology: https://510kreport.com/methodology