# K053394: Nexa Bone Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Nexa Orthopedics, Inc.
- Decided: Dec 14, 2005 after 8 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: 1 generation back to K043583 (2005). 1 ancestor in all.
9 later devices descend from it; 5 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043583: Charlotte Snap-Off Screw, Models 45110001, 45110002, 45110003, Wrightmedicaltechnologyinc (2005) Summary page 1.

## Most influential descendants
- K061620: Ifs Cannulated Bone Screw (2006), 5 descendants of its own
- K063589: Gso Bone Fixation Fasteners (2007), 4 descendants of its own
- K071035: Ifs Bone Fixation Devices (2007), 3 descendants of its own
- K130613: Cannulated Screw and Kirschner (Kwire) System (2014), 1 descendant of its own
- K252758: Cannulated Screw and Kirschner (K wire) System (2025), 0 descendants of its own

## Indications for use
The Nexa bone screw system provides fixation of fractures, fusions, or osteotomies of bones of the hand and foot.

Source page: https://510kreport.com/device/K053394
Methodology: https://510kreport.com/methodology