A device for treating hammertoe deformities has received FDA clearance. Called the HammerLock Nitinol Intramedullary Fixation System, the device is manufactured by the privately held BioMedical Enterprises, Inc. (BME), San Antonio, Texas.
Hammertoe Device Gains FDA Clearance
1 min read Premium comments
Secondary
Company officials report that the device eliminates the use of wires and features a flat body design that resists rotation. In addition, the device has barbs that provide a secure fixation. According to PR Newswire this upgraded version of HammerLock is designed with a linear body that results in a greater bone fusion area at the joint interface which help improve flexibility in positioning and easier reduction. The insertion process is simplified by the new Squeeze-Tab Retention System.
“This new design demonstrates our commitment to both developing new products and improving our existing lines, ” said Keith M. Peeples, BME president and CEO. BME surgeon consultant, Todd Stewart, DPM, stated, “The upgraded HammerLock system is a simple but very impressive improvement.” BME, Inc. is the only U.S. manufacturer of Nitinol metal implants for musculoskeletal and soft tissue fixation.
React:
Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
Join the conversation
Orthopedic professionals are discussing this. Sign in and upgrade to read every comment and add your voice.