# K140970: One-Piece Peek Fusion Implant

- Pathway: 510(k) (Special)
- Applicant: Mtp Solutions, LLC
- Decided: May 13, 2014 after 27 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- 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 K960385 (1996). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133515: Peek Fusion Implant, Mtp Solutions, LLC (2014) Summary page 2.
- K050259: Arthrex Bio-Pin, Arthrex, Inc. (2005) Summary page 2.

## Indications for use
The One-Piece PEEK Fusion Implant is indicated for the fixation of osteotomnies and reconstruction of the lesser toes following correction procedures for hanmmertoe, claw toe and mallet toe.

Source page: https://510kreport.com/device/K140970
Methodology: https://510kreport.com/methodology