US 12349941

US Patent 12349941: Bone Positioning and Cutting System and Method

Title: Bone positioning and cutting system and method

Assignee: Treace Medical Concepts Inc.

Inventors: Paul Dayton, F. Barry Bays

Filing Date: March 25, 2024

Issue Date: July 8, 2025

Abstract: A bone positioning device can include a fixation pin for attachment to a first bone and a fixation pin for attachment to a second bone. A first block having an aperture can be included for slidably receiving a fixation pin, and a second block having an aperture can be included for slidably receiving a fixation pin. A multi-axis joint can connect the first block and the second block, where the multi-axis joint allows the first and second blocks to move with respect to each other about more than one axis.

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Plain-Language Overview of Independent Claims:

US Patent 12349941 contains two independent claims (Claim 1 and Claim 18), both directed to a method of performing bunion surgery. An independent claim stands alone and fully defines an invention without referencing other claims, typically providing the broadest scope of protection.

Independent Claim 1:
This claim describes a method for bunion surgery to correct the alignment between a first metatarsal and a first cuneiform (bones in the foot). The method involves several key steps:

1. Engaging a bone positioning device: This device is attached to the first metatarsal and first cuneiform using fixation pins, spanning the joint between them.
2. Aligning a bone cutting guide: A specialized cutting guide, which has a "joint plate" that extends downward from a "guide feature," is positioned with the joint plate inserted into the joint. The joint plate and guide feature define parallel planes.
3. Cutting the first metatarsal: A cutting tool (like a saw blade) is guided by the guide feature to cut the leading edge of the first metatarsal.
4. Adjusting alignment: The bone positioning device is used to adjust the alignment of the first metatarsal in multiple planes to correct the bunion deformity.
5. Compressing the bones: The first metatarsal and first cuneiform are pressed together.
6. Fixing the position: A bone connector (such as a plate, screw, or pin) is used to permanently secure the adjusted position of the bones.

Independent Claim 18:
Similar to Claim 1, this claim also details a method for bunion surgery to correct the alignment between a first metatarsal and a first cuneiform. The steps are largely the same as Claim 1, but with a specific ordering for the cutting of the cuneiform:

1. Engaging a bone positioning device: The device is attached to the first metatarsal and first cuneiform with fixation pins, extending across the joint.
2. Aligning a bone cutting guide: The cutting guide, with its joint plate inserted into the joint, is aligned.
3. Cutting the first metatarsal: The guide feature of the cutting guide directs a cutting tool to cut the leading edge of the first metatarsal.
4. Adjusting alignment: The bone positioning device is used to adjust the first metatarsal's alignment in multiple planes for bunion correction.
5. Cutting the first cuneiform after alignment adjustment: This is a key distinction, explicitly stating that the leading edge of the first cuneiform is cut after the first metatarsal's alignment has been adjusted by the bone positioning device.
6. Compressing the bones: The first metatarsal and first cuneiform are pressed together.
7. Fixing the position: A bone connector fixes the relative position of the bones.

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Litigation Notes:

The patent US12349941 is currently active and has associated litigation.

• First worldwide family litigation filed: Details are available via Darts-ip.
• US case filed in Delaware District Court: This litigation is publicly accessible via Unified Patents.
• PTAB case PGR2026-00031 filed (Pending): This case is also trackable through Unified Patents.

As of April 26, 2026, the provided information indicates that a PTAB case (PGR2026-00031) has been filed and is pending in 2026, and a US case has been filed in the Delaware District Court. There is no specific mention of a CAFC (Court of Appeals for the Federal Circuit) 2026 docket entry directly within the provided patent text, but the ongoing litigation in the District Court and PTAB may lead to CAFC involvement in the future. I do not have authoritative information to confirm any current CAFC 2026 dockets for this specific patent beyond what is already stated in the patent information regarding the Delaware District Court case and the pending PTAB case.The USPTO database search for US12349941 returned the following information:

Title: Bone positioning and cutting system and method
Assignee: Treace Medical Concepts Inc.
Inventors: Paul Dayton, F. Barry Bays
Filing Date: March 25, 2024
Issue Date: July 8, 2025
Abstract: A bone positioning device can include a fixation pin for attachment to a first bone and a fixation pin for attachment to a second bone. A first block having an aperture can be included for slidably receiving a fixation pin, and a second block having an aperture can be included for slidably receiving a fixation pin. A multi-axis joint can connect the first block and the second block, where the multi-axis joint allows the first and second blocks to move with respect to each other about more than one axis.

Plain-Language Overview of Independent Claims:

US Patent 12349941 contains two independent claims, Claim 1 and Claim 18, both describing methods for performing bunion surgery. An independent claim provides the broadest scope of protection and stands alone without referencing other claims.

Independent Claim 1:
This claim describes a method for correcting a bunion by aligning a first metatarsal and a first cuneiform bone. The method involves:

1. Engaging a bone positioning device: A device is attached to the first metatarsal and the first cuneiform using fixation pins, extending across the joint between them.
2. Aligning a bone cutting guide: A cutting guide, featuring a joint plate offset from a guide feature, is positioned by inserting the joint plate into the joint. The joint plate and guide feature are parallel to each other.
3. Cutting the first metatarsal: A cutting tool is guided by the guide feature to cut a leading edge of the first metatarsal.
4. Adjusting alignment: The bone positioning device is used to adjust the alignment of the first metatarsal in multiple planes to correct the bunion.
5. Compressing the bones: The first metatarsal and the first cuneiform are compressed together.
6. Fixing the position: The adjusted position of the bones is fixed using a bone connector.

Independent Claim 18:
This claim also describes a method for correcting a bunion by aligning a first metatarsal and a first cuneiform, with a specific sequence of cutting steps. The method comprises:

1. Engaging a bone positioning device: A device is engaged with the first metatarsal and first cuneiform using fixation pins, extending across the joint.
2. Aligning a bone cutting guide: A bone cutting guide, with its joint plate offset from a guide feature, is aligned by inserting the joint plate into the joint.
3. Cutting the first metatarsal: The guide feature of the bone cutting guide is used to guide a cutting tool to cut a leading edge of the first metatarsal.
4. Adjusting alignment: The bone positioning device is used to adjust the alignment of the first metatarsal in multiple planes to correct the bunion.
5. Cutting the first cuneiform after alignment adjustment: A leading edge of the first cuneiform is cut specifically after the bone positioning device has been used to adjust the metatarsal's alignment.
6. Compressing the bones: The first metatarsal and the first cuneiform are compressed together.
7. Fixing the position: A bone connector is used to fix the relative position of the first metatarsal to the first cuneiform.

Litigation:

US Patent 12349941 is currently active and is involved in litigation.

• First worldwide family litigation filed (details available from Darts-ip).
• US case filed in Delaware District Court (details available from Unified Patents).
• PTAB case PGR2026-00031 filed (Pending) (details available from Unified Patents).

As of April 26, 2026, the patent text confirms pending litigation in the Delaware District Court and a PTAB case filed in 2026. I do not have authoritative information to confirm any specific CAFC 2026 dockets for patent US12349941 beyond what is explicitly stated in the provided patent details regarding the ongoing District Court and PTAB proceedings.