FIELD ORTHOPAEDICS PTY LTD

Field Orthopaedics Pty Ltd specializes in orthopaedic fixation devices, primarily focusing on non-bioabsorbable bone screws (both sterile and non-sterile) and bone pins. Their product range also includes reusable surgical instruments like drill guides, screwdrivers, depth gauges, and instrument trays, as well as single-use cannulated surgical drill bits. These devices are designed for fracture stabilization, bone alignment, and internal fixation in orthopaedic surgery.

Field Orthopaedics Pty Ltd is based in the United States. Since it operates domestically, its devices must comply with the FDA’s regulatory requirements, including classification under FDA regulations as Class I or Class II, and many of its devices are listed in the FDA’s Unique Device Identifier (UDI) database.

Field Orthopaedics’ devices are primarily listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the United States, ensuring transparency and traceability for healthcare providers and regulators.

Field Orthopaedics’ devices are classified under the FDA’s regulatory framework as either Class I or Class II. Class I devices generally pose minimal risk and may require less stringent controls, while Class II devices involve a higher risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body part it interacts with.

Field Orthopaedics’ devices are tailored for orthopaedic procedures, including fracture stabilization and bone alignment, with a focus on non-bioabsorbable materials for durability. Their portfolio includes both implantable components (like screws and pins) and reusable surgical tools (such as drill guides and screwdrivers), ensuring compatibility for various stages of orthopaedic surgery. The company’s systems, such as the FO NX Nail System and FO Micro Screw System, are designed to meet specific clinical needs in internal fixation.