A fixation system for soft tissue grafts during anterior cruciate ligament reconstruction has been granted FDA 510(k) clearance.
FDA Clears ACL Reconstruction Soft-tissue Fixation System
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Secondary#orthopediatrics#abanza#washercap
According to the FDA’s summary document, the device is “intended for fixation of soft tissue grafts, including tendons and ligaments, during surgical procedures such as in anterior cruciate ligament (ACL) reconstruction of the knee.”
The fixation system is equivalent to the OrthoPediatrics ACL reconstruction system. The fixation system “is a single three-piece device achieving the same intended effect by fastening the soft tissue grafts inside the device which is implanted to the bone.” The fixation system and the predicate device “share the same technological characteristics, including performance, basic design, materials, device usage, sterility and sizes.”
Spain-based ABANZA TECNOMED SL is the manufacturer and submitted the device for FDA 510k clearance. ABANZA is a medical device company focused on developing products for orthopedics and arthroscopic soft tissue repair procedures. The company plans to expand the soft-tissue fixation technology to additional applications.
According to the company, the WasherCap™ is the “first soft-tissue graft fixation device designed to allow surgeons to perform a fixation non-dependent on the bone quality of the patient and with precision and full control.” Its design allows for “a complete entrapment of the soft-tissue” inside the device.
According to the company, “biomechanical tests have demonstrated that ACL reconstructions using the WasherCap™ device provide a higher fixation strength on the tibial side compared to standard tibial fixation devices such as interference screws.”
ABANZA Chief Executive Officer Juan Abascal commented, “The FDA clearance of WasherCap™ is exciting because it offers surgeons a highly reliable solution for soft-tissue graft fixation, especially valuable for young and female patients as well as revision procedures.”
Abascal continued, “WasherCap™ provides a stronger and more rigid tibial fixation, which will support a better ACL surgery outcome.”
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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.
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