Austin, Texas-based Leith Medical, LLC, a medical device startup, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its One Screw, One Step™ foot and ankle plating system with anti-backout technology.
One Screw, One System, One Step Forward
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Secondary#footsurgery#onestep#onescrew
Founded by husband and wife duo Tim and Candace Leak, Leith Medical is “dedicated to changing the way orthopedic surgeries are performed with simple, common sense solutions.” Its flagship product, the One Screw, One Step foot and ankle plating system with anti-backout technology utilizes its One Screw, One Step technology.
The One Screw, One Step system allows “micro-motion to stimulate physiologic bone healing” while simultaneously “prohibiting any screw back-out and fixation failure.” The system boasts a “low profile design” which allows “the screws to sit flush with the bone without prominence regardless of angulation.”
The patented system has made its way into the operating room. Earlier this month Arush Angirasa, DPM, FACFAS, a partner with Southwest Orthopaedic Group, performed the first patient surgery using the system.
Leith Medical CEO Tim Leak told OTW, “There is nothing like our system on the market. Surgeons are blown away at the angles that can be captured and how easily it compresses to the bone without the concern of screw back out.”
Leak continued, “We really are changing the way foot and ankle surgeries are performed, and the greatest part is that it is a simple, common sense solution.”
The initial product launch includes four plate systems. Surgeons will use the first tarsometatarsal, lesser tarsometatarsal, and first metatarsophalangeal joint systems in the forefoot and midfoot. The lateral malleolar fracture plate system is designed for “fixation of a variety of distal fibular fracture patterns.”
The 510(k) clearance also allows the company to launch “additional tibial and fibular plating systems.” Leak commented in the press release, “This is the first of many products we are developing with our One Screw, One Step technology, but for now our primary focus is getting the foot and ankle system into the operating room.”
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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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