DCT
2:24-cv-09763
Treace Medical Concepts Inc v. Stryker Corp
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Treace Medical Concepts, Inc. (Delaware)
- Defendant: Stryker Corporation (Michigan) and Wright Medical Technology, Inc. (Delaware)
- Plaintiff’s Counsel: Stone Conroy LLC
- Case Identification: 2:24-cv-09763, D.N.J., 10/24/2025
- Venue Allegations: Plaintiff alleges that venue is proper in the District of New Jersey because Defendants conduct substantial business in the district, including marketing, selling, and providing training for the accused products, and have purposefully availed themselves of the rights and benefits of the laws of New Jersey.
- Core Dispute: Plaintiff alleges that Defendant’s surgical systems for bunion correction infringe patents related to a bone positioning guide and associated surgical methods.
- Technical Context: The technology concerns orthopedic surgical instruments and methods designed to correct hallux valgus (bunion) deformity by realigning the metatarsal bones of the foot in three dimensions.
- Key Procedural History: The filing is a First Amended Complaint. No other significant procedural events, such as prior litigation or post-grant proceedings involving the patents-in-suit, are mentioned in the complaint.
Case Timeline
| Date | Event |
|---|---|
| 2015-07-14 | Earliest Priority Date for U.S. Patent No. 10,874,446 |
| 2015-08-14 | Earliest Priority Date for U.S. Patent No. 11,039,873 |
| 2020-12-29 | Issue Date for U.S. Patent No. 10,874,446 |
| 2021-06-22 | Issue Date for U.S. Patent No. 11,039,873 |
| 2025-10-24 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 10,874,446 - "Bone Positioning Guide"
The Invention Explained
- Problem Addressed: The patent’s background section states that traditional surgical procedures for correcting misaligned bones in the foot require a surgeon to manually realign and then hold the bones in the corrected position while fixating them, a complex process that can lead to inconsistent treatment results (ʼ446 Patent, col. 1:21-38).
- The Patented Solution: The invention is a C-shaped surgical instrument designed to mechanically realign a first metatarsal with respect to a second metatarsal in three anatomical planes simultaneously (frontal, transverse, and sagittal) (’446 Patent, col. 2:10-14). As depicted in Figure 1, the guide includes a stationary tip (50) that engages one bone and an adjustable bone engagement member (40) on a movable shaft (30) that engages another bone. By actuating a mechanism (e.g., knob 120), the clinician advances the shaft, which moves the first metatarsal into a corrected alignment relative to the second metatarsal (’446 Patent, Abstract; col. 2:1-9).
- Technical Importance: The device provides a mechanical and reproducible method for achieving multi-planar correction of bone deformities, aiming to improve upon the variability of manual surgical techniques (’446 Patent, col. 2:6-22).
Key Claims at a Glance
- The complaint asserts infringement of at least independent claim 1 (Compl. ¶35).
- Claim 1 of the ’446 Patent includes these essential elements:
- a main body member;
- a bone engagement member on one side of the main body member, the bone engagement member being configured to contact a first metatarsal of a foot;
- a tip on another side of the main body member, the tip being configured to contact a metatarsal other than the first metatarsal;
- a depth stop configured to limit a depth of insertion of the tip relative to the metatarsal other than the first metatarsal; and
- a mechanism that allows the bone engagement member and the tip to be moved toward each other.
- The complaint reserves the right to assert additional claims, including dependent claims (Compl. ¶36).
U.S. Patent No. 11,039,873 - "Bone Positioning and Preparing Guide Systems and Methods"
The Invention Explained
- Problem Addressed: Similar to the ’446 Patent, the background addresses the anatomical misalignment of bones, such as in the foot, where surgical intervention is required, and notes that patient discomfort can result from inconsistent manual realignment procedures (’873 Patent, col. 1:24-30).
- The Patented Solution: This patent claims methods for correcting a bunion deformity. The method involves moving a first metatarsal from a misaligned position to an aligned position relative to a second metatarsal by applying a force that causes the bone to both translate and rotate (’873 Patent, col. 1:40-44). The method also includes the steps of preparing the ends of the first metatarsal and the medial cuneiform for fusion, a procedure often accomplished using a bone preparation guide in conjunction with a bone positioning device (’873 Patent, col. 1:47-54).
- Technical Importance: The claimed methods integrate the multi-planar bone realignment with the steps for preparing the bones for fusion, creating a systematic surgical workflow intended to produce more consistent and anatomically correct outcomes (’873 Patent, col. 1:31-39).
Key Claims at a Glance
- The complaint asserts infringement of at least independent claim 1 (Compl. ¶51).
- Claim 1 of the ’873 Patent recites a method with these essential steps:
- preparing an end of a first metatarsal;
- preparing an end of a medial cuneiform separated from the first metatarsal by a tarsal-metatarsal joint;
- after preparing the end of the first metatarsal and after preparing the end of the medial cuneiform, moving the first metatarsal using a bone positioning guide... wherein moving the first metatarsal... comprises moving the first metatarsal... in at least two planes, including a frontal plane and a transverse plane, to establish a moved position of the first metatarsal.
- The complaint reserves the right to assert additional claims (Compl. ¶52).
III. The Accused Instrumentality
Product Identification
- The complaint identifies the Stryker PROstep MICA (Minimally Invasive Chevron Akin) System, including its associated surgical instruments and guides, as the accused instrumentality (Compl. ¶22).
Functionality and Market Context
- The complaint alleges that the PROstep MICA System is a set of instruments and implants used to perform minimally invasive bunion correction surgery (Compl. ¶23). The system allegedly includes a bone positioning guide, analogous to the patented invention, that is used to realign the first metatarsal relative to the second. The complaint further alleges that Stryker provides a surgical technique guide that instructs surgeons on how to use the system's instruments, including cutting guides and the positioner, to perform the allegedly infringing methods (Compl. ¶25, Ex. B). Figure 7 of the complaint, an illustration from the PROstep MICA Surgical Technique guide, shows the surgeon applying multi-planar correction using the accused device (Compl. ¶62).
- The complaint alleges that the PROstep MICA System is a key product line for Stryker in the competitive orthopedic foot and ankle market (Compl. ¶24).
IV. Analysis of Infringement Allegations
U.S. Patent No. 10,874,446 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a main body member | The PROstep MICA System includes a positioning guide with a generally C-shaped frame that spans the patient's foot during surgery. | ¶42 | col. 5:31-44 |
| a bone engagement member... configured to contact a first metatarsal | The positioning guide has an adjustable arm with a concave end that is placed in contact with the medial side of the first metatarsal. | ¶44 | col. 5:63-67 |
| a tip... configured to contact a metatarsal other than the first metatarsal | The stationary arm of the positioning guide has a tip that is placed against the lateral side of the second metatarsal. | ¶46 | col. 6:41-49 |
| a depth stop configured to limit a depth of insertion of the tip | The tip of the positioning guide includes a flared portion that abuts the dorsal surface of the foot, limiting how far the tip can be inserted between the metatarsals. Figure 5 of the complaint, a screenshot from Stryker’s promotional video, depicts this feature. | ¶48 | col. 6:55-56 |
| a mechanism that allows the bone engagement member and the tip to be moved toward each other | The positioning guide includes a threaded shaft connected to a knob, which, when rotated, advances the bone engagement member toward the tip to compress and realign the metatarsals. | ¶50 | col. 5:50-54 |
U.S. Patent No. 11,039,873 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| preparing an end of a first metatarsal | Stryker’s surgical technique guide instructs surgeons to use specific cutting guides and burrs from the PROstep MICA System to resect the articular surface of the first metatarsal. | ¶58 | col. 10:57-62 |
| preparing an end of a medial cuneiform... | Stryker’s surgical technique guide instructs surgeons to use specific cutting guides and burrs from the PROstep MICA System to resect the corresponding articular surface of the medial cuneiform. | ¶60 | col. 10:57-62 |
| after preparing... moving the first metatarsal using a bone positioning guide... in at least two planes, including a frontal plane and a transverse plane... | After preparing the joint surfaces, the surgeon is instructed to apply the PROstep MICA positioning guide and actuate its mechanism to rotate and translate the first metatarsal, correcting the deformity in multiple planes. | ¶62 | col. 10:1-10 |
- Identified Points of Contention:
- Scope Questions: The infringement analysis for the ’446 Patent may focus on the construction of "depth stop." A question for the court will be whether the feature on the accused device, which the complaint alleges limits insertion depth, meets the structural and functional requirements of the claimed "depth stop," particularly if it is not a hard physical stop but rather a visual or tactile guide.
- Technical Questions: For the ’873 Patent, a central question will be one of sequential performance. The infringement allegation hinges on surgeons performing the "preparing" steps before the "moving" step, as recited in claim 1. The analysis may turn on evidence from Stryker’s surgical technique guides, training materials, and expert testimony regarding whether this specific sequence is required, recommended, or consistently performed in practice.
V. Key Claim Terms for Construction
The Term: "depth stop" (’446 Patent, claim 1)
Context and Importance: The definition of this term is critical to the literal infringement analysis for the ’446 Patent. Practitioners may focus on this term because the accused device's mechanism for limiting insertion depth may differ from the specific embodiment shown in the patent, raising a question of claim scope.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification describes the element as a "stop 110 to limit a depth of insertion" (’446 Patent, col. 6:55-56). This functional language does not explicitly require a specific structure, which may support a broader interpretation covering any feature that performs the limiting function.
- Evidence for a Narrower Interpretation: Figure 3A of the ’446 Patent depicts the "stop 110" as a distinct physical shoulder or flange on the tip member. A defendant may argue that this specific embodiment limits the term to a structure that provides a hard physical stop, rather than just a visual guide or change in geometry.
The Term: "after preparing... moving" (’873 Patent, claim 1)
Context and Importance: This temporal language establishes a specific sequence of surgical steps. Infringement of this method claim depends on whether the accused surgical procedure performs these steps in the recited order.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: Parties may argue that in the context of a complex surgical procedure, "after" does not require strict, irreversible sequentiality but can encompass an iterative process where preparation and alignment steps are performed and refined in close succession. The specification describes the overall procedure, and language regarding the mobilization of the joint before alignment could be used to argue for flexibility in the exact order of subsequent steps (’873 Patent, col. 11:31-42).
- Evidence for a Narrower Interpretation: The plain language of the claim recites a clear sequence: first "preparing," then "moving." The summary of the invention also presents the steps in this order (’873 Patent, col. 1:47-54). This linguistic structure suggests that the sequence is a material limitation of the claim.
VI. Other Allegations
- Indirect Infringement: The complaint alleges induced infringement, stating that Defendants provide the PROstep MICA system with instructions, surgical technique guides, and training videos that actively encourage and instruct surgeons to use the system in a manner that directly infringes the asserted method claims (Compl. ¶70-75).
- Willful Infringement: The complaint alleges that Defendants had pre-suit knowledge of the patents-in-suit, at least by virtue of Plaintiff having sent a notice letter, but continued to market and sell the accused system without alteration. This conduct is alleged to be objectively reckless and to constitute willful infringement (Compl. ¶80-85).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of definitional scope: can the term "depth stop," as used in the ’446 Patent, be construed to cover a feature that provides tactile or visual guidance for insertion depth, or is its meaning limited to a hard physical barrier as depicted in the patent’s figures?
- A key evidentiary question will be one of procedural sequence: does the accused PROstep MICA system’s surgical technique, as taught and practiced, require surgeons to complete the bone "preparing" steps before performing the multi-planar "moving" step, as strictly recited by Claim 1 of the ’873 Patent, or does the procedure allow for a different order of operations?
- A third central issue may relate to damages, particularly concerning apportionment and whether the patented features drive demand for the entire accused surgical system, or if the value is attributable to other non-infringing components or features.