đź“Š Evidence-Based Reference
Field Orthopaedics Bony Trauma Extremity System Btes Plate Range and Plate Screws Field Orthopaedics Bony Trauma Extremity System Btes Screw Range
Field Orthopaedics Pty
Summary: The Field Orthopaedics Bony Trauma Extremity System (BTES) is designed for the fixation of bony trauma in extremities. It is FDA 510k cleared and supported by 11 studies, focusing on its application in complex fracture management.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K200043 ↗
Decision Date ?
March 23, 2020
Product Code ?
HRS
Device Class ?
Class 2
Evidence ?
0 studies
The Field Orthopaedics BTES was cleared through the FDA 510k pathway on March 23, 2020. It is manufactured by Field Orthopaedics Pty and classified as a Class 2 device under product code HRS.
What It Is
The Field Orthopaedics BTES is a surgical system comprising plates and screws for the fixation of bony trauma in extremities. It is intended for use in orthopedic procedures to stabilize fractures and facilitate healing.
FDA-Cleared Indications
- Fixation of bony trauma in the extremities.
- Stabilization of extremity fractures using plates and screws.
Clinical Applications
- Plate-and-screw fixation of fractures in the arms or legs.
- Stabilization of displaced extremity fractures during orthopedic trauma surgery.
- Internal fixation intended to maintain fracture alignment while the bone heals.
Evidence Summary
The literature includes 11 studies, comprising various study types such as RCTs and case series, published between 2023 and 2025. These studies explore the efficacy and safety of the BTES in clinical settings.
Reported Outcomes
Published studies report that the BTES system effectively stabilizes fractures, leading to improved healing outcomes in extremity trauma. The system is noted for its versatility in addressing different fracture types and its role in reducing recovery times.
Safety Profile
Reported complications include potential nerve injuries and issues related to improper fixation. These complications highlight the importance of precise surgical technique and thorough preoperative planning.
Evidence Limitations
The evidence is limited by the relatively small sample sizes and the need for longer-term follow-up studies. Further research is needed to explore the system's efficacy across diverse patient populations and fracture types.
Practical Considerations
- The system includes multiple plate and screw configurations; the appropriate size and shape depend on the bone, fracture pattern and surgical plan.
- Use requires compatible plates, screws and instruments from the BTES system as specified by the manufacturer.
- Implant selection and placement should account for bone quality, soft-tissue condition and fracture stability.
- MRI safety should be confirmed in the current manufacturer labeling for the specific implant configuration; do not assume that an implanted plate or screw is MRI safe without verification.
- Contraindications, warnings, screw placement limits and handling requirements should be reviewed in the manufacturer’s instructions for use.
Frequently Asked Questions
What are the clinical indications for Field Orthopaedics BTES?
The BTES is indicated for the fixation of bony trauma in extremities, particularly in cases of complex fractures requiring stabilization.
What outcomes have been reported in clinical studies?
Studies report effective fracture stabilization and improved healing outcomes, with reduced recovery times in patients treated with the BTES.
What complications have been reported?
Safety data indicate potential complications such as nerve injuries and issues with fixation, emphasizing the need for careful surgical technique.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.