Litigation
Untitled case
active1:25-cv-00592
- Filed
- 2025-01-17
Patents at issue (1)
Summary
This active litigation case in the Delaware District Court involves US Patent 12274481.
Case overview & background
Plain-language overview of the case: parties, accused product, patents at issue, and why the suit matters.
This active litigation case, 1:25-cv-00592, in the District of Delaware involves Treace Medical Concepts, Inc., a medical technology operating company known for its Lapiplasty® 3D Bunion Correction® System, as the plaintiff. The defendants are Zimmer Biomet Holdings, Inc. and Paragon 28, Inc., both operating companies in the medical device sector. Treace Medical alleges that the defendants are infringing on its patents through products and surgical techniques related to bunion correction that are purportedly similar to Treace's Lapiplasty® system. The Lapiplasty® system is designed to correct bunion deformities in three dimensions by realigning the entire deviated bone rather than just "shaving off the bump," utilizing specialized instrumentation and titanium plating technology to secure the correction and allow early weight-bearing for patients.
The patents asserted in this case are US Patent Nos. 12,102,368; 12,268,397; 12,268,428; and 12,274,481. US Patent 12,102,368 broadly covers a bone positioning guide used to correct anatomically misaligned bones in procedures like bunion surgery. US Patent 12,268,397 relates to bone cutting guide systems and methods for positioning and cutting bones during surgical procedures such as bone alignment or osteotomy. US Patent 12,268,428 describes a tarsal-metatarsal joint procedure utilizing a fulcrum to correct bone deformities by inserting an instrument between metatarsals and preparing bone ends. US Patent 12,274,481, like the others, pertains to various aspects of Treace Medical's Lapiplasty® 3D Bunion Correction® technologies, encompassing instrumentation, implants, and surgical methods for comprehensive bunion correction.
The case was filed on January 17, 2025, in the United States District Court for the District of Delaware under case number 1:25-cv-00592, and is assigned to Judge Gregory B. Williams. Delaware is a frequently chosen venue for patent litigation, particularly after the TC Heartland Supreme Court decision, due to a high number of major U.S. technology and pharmaceutical companies being incorporated there. The district is recognized for its judicial sophistication, docket reliability, and a well-developed body of patent-specific precedent, making it an attractive forum for patent disputes. This litigation is notable because it pits two major players in the orthopedic medical device market against each other, with the lawsuit being filed shortly after Zimmer Biomet's acquisition of Paragon 28, potentially broadening the scope of challenged products. Treace Medical emphasizes its significant investment in pioneering research and an extensive patent portfolio, which includes 80 granted U.S. patents, 26 international patents, and over 150 pending applications, to protect its leadership in instrumented 3D bunion correction.
Key legal developments & outcome
Major rulings, motions, claim construction, settlements, and the present posture or final disposition.
The patent infringement litigation Treace Medical Concepts, Inc. v. Zimmer Biomet Holdings, Inc. et al., Case No. 1:25-cv-00592, is active in the Delaware District Court before Judge Gregory B. Williams. The case involves US Patent 12274481, among others.
Here's a chronological summary of the key legal developments:
1. Filing & Initial Pleadings:
- Complaint Filed (2025-05-12): Treace Medical Concepts, Inc. initiated the lawsuit against Zimmer Biomet Holdings, Inc. and Paragon 28, Inc., alleging infringement of four patents (US Patent Nos. 12,102,368; 12,268,397; 12,268,428; and 12,274,481). The complaint focuses on the defendants' alleged infringement related to Treace's Lapiplasty® system used in bunion correction surgery.
- Amended Complaint Filed (2025-08-05): Treace Medical Concepts, Inc. filed an amended complaint, asserting infringement of an additional patent.
2. Pre-trial Motions of Substance:
- Defendants' Motion to Dismiss (2025-12-19): Zimmer Biomet Holdings, Inc. and Paragon 28, Inc. filed a motion to dismiss certain patent claims, claims of willful infringement, and all claims against Zimmer Biomet Holdings, Inc. As of May 29, 2026, the outcome of this motion is not publicly available through the conducted searches.
- Motion to Sever and Consolidate (2026-03-10): Treace Medical Concepts, Inc. filed motions to sever and to consolidate cases, specifically referencing this case (1:25-cv-00592) and a related case, Paragon 28, Inc. et al v. Treace Medical Concepts, Inc. et al (1:25-cv-01092-GBW). The related case was filed on August 29, 2025, by Paragon 28 and Disior Oy against Treace Medical Concepts. The outcome of these motions is not yet publicly available.
3. Discovery Milestones:
- Proposed Scheduling Order (2026-04-28): A notice was filed regarding the submission of a Proposed Scheduling Order and a request for a scheduling conference. This indicates the parties are moving towards setting discovery deadlines and other pre-trial milestones.
4. Claim Construction (Markman) Outcomes:
- As of the current date, no Markman hearing has been held or a claim construction order issued in this case, based on available public information.
5. Trial Events, Verdict, and Post-Trial Motions:
- The case is still in the pre-trial phase, and no trial events, verdicts, or post-trial motions have occurred.
6. Settlement, Dismissal, Judgment, or Appeal:
- The litigation remains active, with no final disposition (settlement, dismissal, or judgment) reported.
7. Parallel PTAB IPR/PGR Proceedings:
- A targeted search of the USPTO's Patent Trial and Appeal Board (PTAB) databases (P-TACTS and Unified Patents Portal) for US Patent 12274481 does not show any active or concluded Inter Partes Review (IPR) or Post-Grant Review (PGR) proceedings as of May 29, 2026.
Plaintiff representatives
Counsel of record for the plaintiff(s): attorneys, firms, and roles (lead counsel, of counsel, local counsel).
- Heyman Enerio Gattuso & Hirzel
- Dominick T. Gattuso · local counsel
In the patent infringement case Treace Medical Concepts Inc v. Zimmer Biomet Holdings Inc et al. (1:25-cv-00592) in the Delaware District Court, the following attorneys are listed as counsel of record representing the plaintiff, Treace Medical Concepts, Inc.:
- Dominick T. Gattuso
- Role: Likely local counsel
- Firm: Heyman Enerio Gattuso & Hirzel LLP, Wilmington, DE
- Experience Note: Also represents Treace Medical Concepts, Inc. in related patent litigation, such as Paragon 28, Inc. et al v. Treace Medical Concepts, Inc. et al (1:25-cv-01092).
Further information regarding the specific roles (e.g., lead counsel), firms, office locations, and detailed patent litigation experience for the other listed attorneys—Michael A. Meneghini, Olivia A. Wogon, Robert T. Vlasis, III, and Nimalka R. Wickramasekera—was not explicitly detailed in the provided search results from public docket monitoring services. These attorneys appear on docket listings for the plaintiff, suggesting their involvement in the case, but their firm affiliations and specific roles (e.g., lead counsel from a non-Delaware firm or additional local counsel) require further investigation through official PACER docket entries or firm websites, which were not directly accessible or sufficiently detailed in the provided snippets.
Defendant representatives
Counsel of record for the defendant(s): attorneys, firms, and roles (lead counsel, of counsel, local counsel).
- In-house counsel
- Amy Dudash · Counsel for Paragon 28, Inc.
The patent infringement case 1:25-cv-00592, filed in the District of Delaware on January 17, 2025, involves Treace Medical Concepts, Inc. as the plaintiff and names Zimmer Biomet Holdings, Inc. and Paragon 28, Inc. as defendants. The case has been assigned to Judge Gregory B. Williams.
As of the current date, May 29, 2026, details regarding the specific counsel representing the defendants in this case are emerging.
Defendant Representatives:
- Amy Dudash
- Role: Counsel for Paragon 28, Inc.
- Firm: (Firm not explicitly stated in the provided snippets, but she has filed documents on behalf of Paragon 28, Inc. in related proceedings).
- Note on experience: Actively filing documents in related cases involving Paragon 28, Inc., including stipulations and notices related to potential damages and extensions of time.
While the docket for 1:25-cv-00592 directly identifying lead and local counsel for Zimmer Biomet Holdings, Inc. and Paragon 28, Inc. is not fully detailed in the provided search results, Amy Dudash has been identified as counsel for Paragon 28, Inc. in related proceedings, actively participating in filings as recently as March 2026. It is common for counsel to appear for both defendants in cases where there is an acquisition, such as Zimmer Biomet's acquisition of Paragon 28 in April 2025, which occurred shortly before this lawsuit was filed. Further details would require a direct review of the complete docket for 1:25-cv-00592.