# K193345: Arthrex DynaNite Compression Plate

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Jul 8, 2020 after 218 days
- Product code: HRS (Plate, 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: 7 generations back to K964226 (1997). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161303: dynaMX™ Compression Plate, Mx Orthopedics, Corp. (2017) Summary page 4.
- K090047: Synthes (Usa) 1.5MM Mini Fragment LCP System, Synthes (Usa) (2009) Summary page 4.

## Indications for use
The Arthrex DynaNite Compression Plate 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. The Arthrex DynaNite Compression Plate is intended to be used in conjunction with the Arthrex Compression FT Screws.

Source page: https://510kreport.com/device/K193345
Methodology: https://510kreport.com/methodology