# K053408: Nexa Bone Plate and Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Nexa Orthopedics, Inc.
- Decided: Dec 22, 2005 after 15 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: 1 generation back to K051884 (2005). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051884: Charlotte Small MTP Fusion Plate, Wrightmedicaltechnologyinc (2005) Summary page 1.

## Indications for use
The bone plate and screw system is intended for use in providing fixation during fractures, fusions and osteotomies. The system consists of plates and screws for treatment of the phalanges, and metatarsals bones.

Source page: https://510kreport.com/device/K053408
Methodology: https://510kreport.com/methodology