Treace Medical Concepts, Inc., a medical device company headquartered in Ponte Vedra Beach, Florida, and Fusion Orthopedics, LLC, a medical equipment manufacturer based in Mesa, Arizona, have come to an agreement to resolve their legal dispute.
Treace Medical Concepts and Fusion Orthopedics Reach Settlement
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The lawsuit was initiated in March 2022 by Treace Medical. Treace Medical made a number of allegations against Fusion Orthopedics including patent infringement, trademark infringement, and copyright infringement. Treace Medical also made allegations regarding unfair trade practices. The allegations, per the press release, were based on “Fusion Orthopedics’ use, sale, and promotion of the Lapilock 4D Advanced Bunion Surgery, including false advertising and unfair competition.”
In August 2022, Fusion Orthopedics announced the full commercial release of its LapiLock 4D Advanced Bunion Surgery. According to the LapiLock website, “The patented 4D Advanced Bunion Surgery by Fusion Orthopedics provides realignment and 13+ unique implant options for bunion surgery depending on surgeon preference and patient needs.”
Fusion Orthopedics subsequently filed its own counterclaims against Treace Medical. According to the press release, Fusion Orthopedics requested “declaratory judgment of non-infringement and invalidity of the patents, declaratory judgment of invalidity of Treace Medical’s LAPIPLASTY trademark.” It also made claims of unfair trade practices based on “Treace Medical’s use, sale, and promotion of the Lapiplasty 3D Bunion Correction, including counterclaims of false descriptions and false advertising.”
According to the Lapiplasty 3D Bunion Correction website, Lapiplasty® 3D Bunion Correction™ is “patented, advanced technology designed to correct all 3 dimensions of the bunion at the root of the problem (unstable joint).” Additionally, according to Treace Medical Concepts initial complaint, the company claims “its patented surgical methods seek to restore the natural biomechanical structure of the foot by restoring the tri-planar alignment of the patient’s big toe, or more specifically, the relative orientation of the medial cuneiform and first metatarsal bones and the cuneiform-metatarsal joint.” This purportedly “allows patients to walk in a surgical boot within days of the surgery.”
According to the press release regarding the settlement, “Fusion Orthopedics pleased with the outcome.” The terms of the settlement are confidential, and documents related to the settlement were filed under seal.
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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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