# K180348: Field Orthopaedics Micro Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Field Orthopaedics Pty, Ltd.
- Decided: Jul 17, 2018 after 159 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: 5 generations back to K962616 (1996). 19 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051567: Aptus Titanium Osteosynthesis System, Medartis, Inc. (2005) Summary page 4.
- K100736: Kirschner and Guide Wires, Smt Schilling Metalltechnik GmbH (2010) Summary page 4.

## Most influential descendants
- K200043: Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws; Field Orthopaedics Bony Trauma Extremity System (BTES) Screw Range (2020), 1 descendant of its own
- K241695: Extremity All Suture System (2024), 0 descendants of its own
- K230118: Bony Trauma Extremity System (BTES) Screw Range, NX Nail (2023), 0 descendants of its own

## Indications for use
The Field Orthopaedics Micro Screw System consists of the following kits with the following indications: The FO Micro Screw Kit is intended for fixation of fractures, osteotomies, and arthrodeses of small bones in the foot, hand, and forearm. The FO Pin and Wire Kit is intended for fixation and stabilization of bone fractures or as guidance at insertion of implants into the skeletal system.

Source page: https://510kreport.com/device/K180348
Methodology: https://510kreport.com/methodology