# K230118: Bony Trauma Extremity System (BTES) Screw Range, NX Nail

- Pathway: 510(k) (Special)
- Applicant: Field Orthopaedics Pty, Ltd.
- Decided: Feb 16, 2023 after 30 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: 13 generations back to K962616 (1996). 127 ancestors in all.
No later device cites it as a predicate yet.
0 of 128 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200043: Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws; Field Orthopaedics Bony Trauma Extremity System (BTES) Screw Range, Field Orthopaedics Pty, Ltd. (2020) Summary page 4.

## Indications for use
The Field Orthopaedics BTES Screw Range is intended for use in the fixation of fractures, osteotomies, and arthrodesis, appropriate for the size of the device, in adults and in both, children (2-12 years) and adolescents (12- 21 years), in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The FO Fenestrated Screws are not for the delivery of bone graft, bone cement, or bone void filler. The Field Orthopaedics BTES Plate Range and Plate Screws are intended for use in the fixation of fractures, osteotomies, and arthrodesis of the hand and other small bones. The system may be used in both adults and pediatric patients.

Source page: https://510kreport.com/device/K230118
Methodology: https://510kreport.com/methodology