# Field Orthopaedics Pty, Ltd.

- Location (FDA's records): Teneriffe, AU
- FDA decisions: 4 (2018–2024): 4 510(k) clearances
- Names in FDA's records: Field Orthopaedics Pty, Ltd. (3); Field Orthopaedics (1)
- Product codes: HWC (2), HRS (1), MBI (1)
- 510(k) review time since 2016: median 84 days, against 96 for FDA's reviews in the same codes and years (2 of 4 faster)
- Predicates its devices cite: 12 (3 its own); citations of its devices by later devices: 3 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medartis AG: 2 (https://510kreport.com/company/medartis)
- Arthrex, Inc.: 2 (https://510kreport.com/company/arthrex)
- Memometal Technologies: 1 (https://510kreport.com/company/memometal-technologies)
- Osteomed LP: 1 (https://510kreport.com/company/osteomed)
- Synthes (Usa): 1 (https://510kreport.com/company/synthes-usa)
- Synthes (USA) Products, LLC: 1 (https://510kreport.com/company/synthes-usa-products)
- Smt Schilling Metalltechnik GmbH: 1 (https://510kreport.com/company/smt-schilling-metalltechnik)

## Its most-cited devices
- K180348: Field Orthopaedics Micro Screw System (2018), cited by 2
- K200043: Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws; Field Orthopaedics Bony Trauma Extremity System (BTES) Screw Range (2020), cited by 1

## Recent decisions
- K241695: Extremity All Suture System (Sep 12, 2024)
- K230118: Bony Trauma Extremity System (BTES) Screw Range, NX Nail (Feb 16, 2023)
- K200043: Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws; Field Orthopaedics Bony Trauma Extremity System (BTES) Screw Range (Mar 23, 2020)
- K180348: Field Orthopaedics Micro Screw System (Jul 17, 2018)

Source page: https://510kreport.com/company/field-orthopaedics