# K172052: Arthrex DynaNite Nitinol Staple

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Dec 13, 2017 after 160 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: 4 generations back to K902307 (1990). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043059: Compression Staple and Simple Staple, Wrightmedicaltechnologyinc (2005) Summary page 4.
- K153129: dynaMX Tabbed Staple, Mx Orthopedics, Corp. (2016) Summary page 4.
- K993714: Memograph Staple, Warm System, Biomedical Ent., Inc. (2000) Summary page 4.

## Most influential descendants
- K243742: Arthrex DynaNite Nitinol Staples (2025), 0 descendants of its own

## Indications for use
The Arthrex DynaNite Nitinol Staple is intended to be used for fixation such as: LisFranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot and hindfoot arthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.

Source page: https://510kreport.com/device/K172052
Methodology: https://510kreport.com/methodology