Flow-FX announces new 510K for the innovative LAGLOCK™ enhancement to its Flow-Nail™ product line

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Flow-FX LLC, a paradigm expanding orthopaedic device company in Mokena, Il continues to break new ground with its newly issued 510k, K221115, for the LAGLOCK™ enhancement to its Flow-Nail product line™.

Lag Screw Hook is deployed with Peg into pocket of Trochanteric Intramedullary Nail (IM Nail)

Lag Screw Hook (depicted in red) is deployed with Peg (depicted in yellow) into pocket of Trochanteric IM Nail (depicted in blue)

The patent pending Flow-Nail™ with LAGLOCK™ is already the only trochanteric nail system patented and 510k cleared for fracture fixation and delivery of bone void fillers. In addition, it now has the first and only through the lag screw static locking mechanism.

Flow-FX LLC, the orthopaedic device company in Mokena, Il continues to raise the standard with its groundbreaking newly issued FDA 510(k) clearance, K221115. The patent pending Flow-Nail™ with LAGLOCK™ is already the only trochanteric nail system patented and 510(k)-cleared for fracture fixation and delivery of bone void fillers. In addition, it now has the first and only through-the-lag screw static locking mechanism.

The 510(k) related testing showed that this enhancement maintains Flow-Nail’s fatigue and static strength characteristics while providing previously unheard-of axial strength. Comparing LAGLOCK to other static mechanisms on the market that tend to slip, or create stress points for screw breakage, and fail at a much lower load, the LAGLOCK did not slip or fail but did max out an axial load cell at 440lb!

Many studies have shown reduced screw cutout with femoral head augmentation, while others have shown the value of a static locking mechanism for certain unstable fractures. Flow-Nail with LAGLOCK now offers the best of both technologies!

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Patrick Sweeney MD, CEO
Flow-FX LLC
1 (815) 531-4424
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