This section highlights FDA-related milestones and regulatory updates for drugs developed by Orthofix Medical (OFIX).
Over the past two years, Orthofix Medical has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Orthofix's and TrueLok. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Orthofix's proprietary Pulsed Electromagnetic Field - FDA Regulatory Timeline and Events
Orthofix's proprietary Pulsed Electromagnetic Field is a drug developed by Orthofix Medical for the following indication: Patients treated with the SpinalStim™ bone growth therapy device.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Orthofix's proprietary Pulsed Electromagnetic Field
- Announced Date:
- September 23, 2024
- Indication:
- Patients treated with the SpinalStim™ bone growth therapy device
Announcement
Orthofix Medical Inc. announced the presentation of new data supporting the use of Orthofix's proprietary Pulsed Electromagnetic Field (PEMF) stimulation to increase fusion rates as an adjunct to lumbar spine fusion surgery. Patients treated with the SpinalStim™ bone growth therapy device demonstrated a high rate of successful fusion with significant improvements in pain, function and quality of life, despite having risk factors for pseudarthrosis.
AI Summary
Orthofix Medical Inc. has released new data showing that its Pulsed Electromagnetic Field (PEMF) stimulation, when used as an adjunct to lumbar spine fusion surgery, can significantly boost fusion rates. The study detailed the use of the SpinalStim™ bone growth therapy device, which helped patients achieve a high rate of successful spinal fusion. Despite many patients presenting risk factors for pseudarthrosis, the treatment led to considerable improvements in pain relief, functional ability, and overall quality of life. These positive results suggest that adding PEMF stimulation to standard lumbar spine fusion procedures may strengthen patient outcomes and accelerate recovery. This advancement highlights the potential of innovative bone growth therapies to enhance the healing process, offering a promising new approach in the realm of spinal surgery.
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TrueLok EVO Ring Fixation System - FDA Regulatory Timeline and Events
TrueLok EVO Ring Fixation System is a drug developed by Orthofix Medical for the following indication: Complex limb reconstruction and deformity correction procedures.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TrueLok EVO Ring Fixation System
- Announced Date:
- March 19, 2025
- Indication:
- Complex limb reconstruction and deformity correction procedures
Announcement
Orthofix Medical Inc announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance and the European CE Mark for the TrueLok™ Elevate Transverse Bone Transport (TBT) System.
AI Summary
Orthofix Medical Inc. recently announced that it has received U.S. FDA 510(k) clearance and the European CE Mark for its new TrueLok™ Elevate Transverse Bone Transport (TBT) System. This achievement marks the first time a dedicated system for transverse bone transport has met these regulatory standards.
The TrueLok Elevate system is designed to preserve limbs by addressing bony and soft tissue deformities, such as those seen in patients with diabetic foot ulcers and chronic wounds. By creating a tibial bone segment that is gradually distracted over several days, the system aims to improve blood flow and promote wound healing. Now available in a limited market release in the U.S. and select international markets, the device offers a promising treatment option for patients facing complex limb conditions and may help reduce the rate of amputations in high-risk populations.
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