# K133515: Peek Fusion Implant

- Pathway: 510(k) (Traditional)
- Applicant: Mtp Solutions, LLC
- Decided: Mar 28, 2014 after 133 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: 4 generations back to K960385 (1996). 17 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050259: Arthrex Bio-Pin, Arthrex, Inc. (2005) Summary page 1.
- K130412: Osteomed Extremifuse System, Osteomed (2013) Summary page 1.
- K110445: Flexfusion (TM) Fixation Implant, Nextremity Solutions, LLC (2011)

## Most influential descendants
- K211996: Nexta PEEK Hammertoe Correction System (2021), 0 descendants of its own
- K140970: One-Piece Peek Fusion Implant (2014), 0 descendants of its own

## Indications for use
The PEEK Fusion Implant is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.

Source page: https://510kreport.com/device/K133515
Methodology: https://510kreport.com/methodology