Sole Proprietors? Treace Puts Its Foot Down in lawsuit against Zimmer Biomet and Paragon 28

Treace Medical Concepts, Inc. has filed a lawsuit against Zimmer Biomet Holdings, Inc. and Paragon 28, Inc., accusing the two companies of infringing on four of its patents (Patent No. 12,102,368; Patent No. 12,268,397; Patent No. 12,268,428; Patent No. 12,274,481) related to the Lapiplasty® system. This system is used in bunion correction surgery and was designed to improve upon older surgical methods that Treace says were less effective.

In the complaint, Treace alleges that the defendants are selling products that are too similar to the patented features of the Lapiplasty® system, including both the surgical tools and the techniques used during the procedure. Treace emphasizes that its system is unique in how it corrects bunions in three dimensions and guides the surgeon through each step to produce more consistent results for patients.

The timing of the lawsuit is notable, coming shortly after Zimmer Biomet finalized its acquisition of Paragon 28 in April 2025 for approximately $1.2 billion. As a result of the deal, Treace may now be challenging a broader range of products that include Paragon’s technologies, which could overlap with Treace’s intellectual property.

Treace has highlighted the strength of its patent portfolio, which includes 80 granted U.S. patents, 26 issued in other countries, and more than 150 pending applications. The company points to this as evidence of its leadership in the field of instrumented 3D bunion correction and suggests that its legal actions are part of a strategy to protect the innovations it has invested heavily in developing.

In addition to seeking financial damages, Treace is asking the court to stop the defendants from making, using, or selling the products it claims are infringing.

The case has been assigned to Judge Gregory B. Williams in the U.S. District Court of Delaware Case No. 1:25-cv-00592.

Complaint