DCT

2:26-cv-00188

Conventus Orthopaedics Inc v. Fusion Orthopedics USA LLC

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:26-cv-00188, D. Ariz., 01/09/2026
  • Venue Allegations: Venue is alleged to be proper in the District of Arizona because the Defendant maintains a regular and established place of business in the district and has committed the alleged acts of infringement within the district.
  • Core Dispute: Plaintiff alleges that Defendant’s FibFix Nail System, an orthopedic implant, infringes two patents related to flexible intramullary devices for stabilizing bone fractures.
  • Technical Context: The technology resides in the field of orthopedic medical devices, specifically intramullary nails designed for the minimally invasive fixation of bone fractures, a significant segment of the surgical device market.
  • Key Procedural History: The complaint notes that the two asserted patents belong to the same patent family and claim priority to the same provisional applications. Plaintiff Conventus Orthopaedics, Inc. acquired Flower Orthopedics, Inc. in May 2020, forming the entity Conventus Flower. No prior litigation or post-grant proceedings are mentioned in the complaint.

Case Timeline

Date Event
2015-07-13 Earliest Priority Date for ’929 and ’838 Patents
2018-11-27 U.S. Patent No. 10,136,929 Issues
2019-12-03 U.S. Patent No. 10,492,838 Issues
2026-01-09 Complaint Filed

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 10,136,929: *"Flexible Bone Implant"* (Issued Nov. 27, 2018)

The Invention Explained

  • Problem Addressed: The patent background describes challenges with existing bone fracture treatments. Bone plates often require extensive surgical exposure of the bone, leading to lengthy and painful healing, while external fixation devices carry a significant risk of infection. (’929 Patent, col. 1:25-44). The patent identifies a need for implants that avoid broad surgical exposure while minimizing infection probability. (’929 Patent, col. 1:38-44).
  • The Patented Solution: The invention is an intramedullary bone implant featuring an elongate body with a flexible, threaded distal portion and a more rigid proximal portion. (’929 Patent, Abstract). The key innovation is that the distal portion is designed to be flexible enough to bend and follow a curved path, such as the natural intramedullary canal of a bone, during insertion. (’929 Patent, col. 2:55-58). This allows the stiffer proximal portion to span and stabilize a fracture without requiring the implant itself to force a straight path through the bone, as illustrated in Figures 8-10 of the patent. (’929 Patent, col. 2:58-65).
  • Technical Importance: This design enables minimally invasive surgical fixation of fractures, particularly in bones with natural curvature, potentially reducing surgical trauma and recovery time. (Compl. ¶13).

Key Claims at a Glance

  • The complaint asserts independent claim 18 and dependent claim 19. (Compl. ¶8).
  • The essential elements of independent claim 18 include:
    • An elongate body with a distal portion and a proximal portion.
    • The distal portion has a helical thread and is "operable to bend as it is threaded into a bone to follow a curved path."
    • The distal portion has a bending stiffness lesser than the proximal portion, with a specific stiffness ratio between 2:1 and 20:1.
    • The minor diameter of the distal thread is "uninterrupted along an entire length of the helical distal thread."
  • The complaint notes that Defendant infringes "one or more claims" and reserves the right to assert additional claims. (Compl. ¶22).

U.S. Patent No. 10,492,838: *"Flexible Bone Implant"* (Issued Dec. 3, 2019)

The Invention Explained

  • Problem Addressed: As a member of the same patent family, the ’838 Patent addresses the same problems of reducing surgical exposure and infection risk associated with traditional bone fracture fixation methods. (’838 Patent, col. 1:24-44).
  • The Patented Solution: The ’838 Patent also discloses a flexible intramedullary implant. The claims focus on a specific geometry where an "elongate, headless, proximal portion" has a smooth outer surface and a diameter that is "greater than or equal to the major diameter of the distal screw thread." (’838 Patent, col. 5:24-27). This configuration allows the flexible threaded distal portion to navigate a curved path for fixation, while the larger-diameter smooth proximal portion can fill the intramedullary canal to provide stable support across a fracture. (’838 Patent, col. 4:54-63; Fig. 1).
  • Technical Importance: The combination of a flexible threaded tip with a larger, smooth, canal-filling body provides for stable bone fixation through a minimally invasive approach. (Compl. ¶¶12, 13).

Key Claims at a Glance

  • The complaint asserts claims 15 and 20, with claim 20 being the independent claim explicitly analyzed. (Compl. ¶¶8, 11).
  • The essential elements of independent claim 20 include:
    • A body with a proximal and distal end.
    • An elongate distal portion with a continuous distal screw thread.
    • An "elongate, headless, proximal portion" with a smooth outer surface, whose diameter is greater than or equal to the major diameter of the distal screw thread.
    • The proximal portion has a driver engagement feature centered on the longitudinal axis.
    • The elongate distal portion is "operable to bend as it is threaded into a bone to follow a curved path."
  • The complaint reserves the right to assert additional claims. (Compl. ¶26).

III. The Accused Instrumentality

  • Product Identification: The accused product is the FibFix™ Nail System, manufactured and marketed by Defendant Fusion Orthopedics. (Compl. ¶8).
  • Functionality and Market Context: The FibFix Nail System is described in Defendant's marketing materials as a "low-profile intramedullary nail system designed for fibular stabilization following fibula fractures and osteotomies." (Compl. ¶10). The complaint alleges the system incorporates features that correspond to the patented technology, including a "Dual Helix Thread Design" on its distal portion, a smooth proximal portion, and "FlexZone™ Technology" which is described as providing "optimized strength and controlled flexibility for dynamic load sharing." (Compl. ¶¶12, 13, 14, 18). An annotated diagram of the accused product highlights these specific features. (Compl. p. 6, Fig. 1). The complaint alleges the product is made from titanium alloy. (Compl. ¶20).

IV. Analysis of Infringement Allegations

The complaint provides a narrative infringement theory primarily focused on claim 20 of the ’838 Patent, supported by excerpts from the Defendant's product literature.

’838 Patent Infringement Allegations

Claim Element (from Independent Claim 20) Alleged Infringing Functionality Complaint Citation Patent Citation
a body defining a longitudinal axis extending between a proximal end and a distal end The accused FibFix Nail is an intramedullary nail system that includes a nail body extending from a proximal to a distal end. ¶12 col. 2:58-62
an elongate distal portion of the body having an outer surface defining a continuous distal screw thread... The product literature for the FibFix Nail System describes a “Dual Helix Thread Design” that extends along the distal portion of the nail. ¶13 col. 2:55-57
an elongate, headless, proximal portion of the body having a smooth outer surface... The proximal portion of the FibFix Nail is allegedly designed to be smooth, as described by the "Anatomical Distal Design" in product literature. ¶14 col. 5:24-27
...the diameter of the elongate, headless, proximal portion being greater than or equal to the major diameter of the distal screw thread... The complaint alleges that product documentation and sizing information confirm this dimensional relationship. ¶15 col. 2:62-65
...the proximal portion having a driver engagement feature centered on and aligned with the longitudinal axis The complaint alleges that the product's design for "easy insertion and removal" necessitates a driver engagement feature. ¶19 col. 4:65-68
wherein the elongate distal portion is operable to bend as it is threaded into a bone to follow a curved path Defendant's marketing materials allegedly highlight the product's "FlexZone Technology" and its ability to provide "controlled flexibility." ¶18 col. 2:55-58
  • Identified Points of Contention:
    • Scope Questions: A central dispute may concern the meaning of "operable to bend as it is threaded into a bone to follow a curved path." The question is whether the "controlled flexibility for dynamic load sharing" attributed to the accused product's "FlexZone Technology" (Compl. ¶18) is the same as the specific bending-during-insertion function required by the claims. The complaint does not contain sufficient detail for analysis of the specific bending stiffness ratio of 2:1 to 20:1 required by claim 18 of the ’929 Patent, which will likely require expert testimony and technical evidence beyond the marketing materials provided.
    • Technical Questions: What is the function of the "Universal Syndesmosis (Proximal) Holes" shown in the product literature? (Compl. p. 8, Fig. 4). The complaint alleges these are for screw insertion, but their presence may raise questions about how the proximal end of the nail functions and whether it meets the "smooth outer surface" limitation in a way consistent with the patent's teachings.

V. Key Claim Terms for Construction

  • The Term: "operable to bend as it is threaded into a bone to follow a curved path"
  • Context and Importance: This limitation appears in the asserted independent claims of both patents and describes the core functional innovation. Practitioners may focus on this term because the infringement case hinges on mapping the accused product's "FlexZone Technology" to this specific claimed function. (Compl. ¶18).
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification makes general statements that the "distal threaded portion 104 is operable to bend as it is threaded into a bone to follow a curved path." (’838 Patent, col. 2:55-58). This language could be argued to encompass any intramedullary implant designed with a flexible distal section that bends during threaded insertion.
    • Evidence for a Narrower Interpretation: The specification provides specific examples, stating the path may be defined by "a curved hole in the bone, a guide wire, or a natural bone feature such as a non-linear intramedullary canal." (’838 Patent, col. 3:1-5). It also explicitly distinguishes the invention from prior art implants that "continue in a straight line" and "deviate from the curved path." (’838 Patent, col. 3:6-9). This may support a narrower construction requiring that the bending be guided by a pre-existing anatomical or surgically created curve, rather than just being a result of inherent material flexibility.

VI. Other Allegations

  • Indirect Infringement: The complaint does not plead a separate count for indirect infringement. However, the allegations that Defendant markets the FibFix Nail System and provides product documentation and marketing materials could potentially support a future claim for induced infringement, based on the theory that these materials instruct surgeons on how to use the device in an infringing manner. (Compl. ¶¶8, 9, 10).
  • Willful Infringement: The complaint alleges that Defendant's infringement is "willful, deliberate, and in disregard of Conventus' rights." (Compl. ¶¶23, 27). The stated basis for willfulness is constructive notice provided by the issuance of the Asserted Patents. (Compl. ¶30).

VII. Analyst’s Conclusion: Key Questions for the Case

  • A core issue will be one of functional definition: Does the accused product’s “FlexZone Technology,” marketed as providing “controlled flexibility for dynamic load sharing,” perform the specific function of being “operable to bend as it is threaded into a bone to follow a curved path” as required by the patent claims, or is there a fundamental mismatch in the technologies' intended purpose and operation?
  • A key evidentiary question will be one of quantitative proof: Can Plaintiff produce technical evidence, beyond marketing materials, to demonstrate that the accused nail system meets the specific dimensional and performance requirements of the claims, such as the explicit bending stiffness ratio of 2:1 to 20:1 recited in claim 18 of the ’929 Patent?
  • A third question will be one of claim scope: How will the term "headless," as used in claim 20 of the '838 Patent, be construed in light of the accused product's proximal end, which includes a driver engagement feature and transverse holes for fixation screws?