# K172205: ExoToe Staple

- Pathway: 510(k) (Traditional)
- Applicant: Exotoe, LLC
- Decided: Jan 11, 2018 after 174 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: 5 generations back to K902307 (1990). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161587: Memodyn Staple, Austin & Associates, Inc./Telos Medical Equipment (2017) Summary page 4.
- K121277: Z-Snap Off Screw, Z-Double Thread Compression Screw, Z-Guide Wire, Z-Staple, Z-Medical GmbH & Co. KG (2012) Summary page 4.
- K140358: Compressyn Staple, Dallen Medical, Inc. (2014) Summary page 4.

## Indications for use
ExoToe Staple is intended for fracture and osteotomy fixation and joint arthrodesis of the foot in conjunction with k-wire fixation.

Source page: https://510kreport.com/device/K172205
Methodology: https://510kreport.com/methodology