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Catalyst OrthoScience's Shoulder Fracture System Receives FDA Clearance

• Catalyst OrthoScience received FDA 510(k) clearance for its Catalyst Fracture Shoulder System, designed for reverse shoulder arthroplasty in proximal humeral fractures. • The system addresses challenges in tuberosity fixation and healing, a critical aspect of treating proximal humeral fractures with reverse shoulder arthroplasty. • The Catalyst Fracture System includes features like a tuberosity-specific fossa, retention rails, and uncemented diaphyseal fixation for enhanced stability. • A limited user release is planned before broader commercial availability in 2025, expanding Catalyst's portfolio in the orthopedics market.

Catalyst OrthoScience Inc. has announced FDA 510(k) clearance and successful initial surgeries using its Catalyst Fracture Shoulder System, a reverse shoulder arthroplasty (RSA) system specifically designed for treating proximal humeral fractures (PHFs). This advancement addresses the increasing use of RSA for PHFs and the challenges associated with tuberosity fixation and healing.

Addressing Tuberosity Fixation in Proximal Humeral Fractures

According to Dr. Steven Goldberg, chief medical officer of Catalyst, ensuring tuberosity fixation and healing is a critical challenge in treating PHFs. Traditional reverse implants are primarily designed for shoulder arthritis, making them less suited for the unique demands of fracture treatment. The Catalyst Fracture System is engineered to meet the specific complexities of PHFs.
Dr. John A. Brown from The CORE Institute AZ, a co-designer, emphasized the system's significance in enhancing tuberosity fixation and healing, leading to improved patient outcomes in both hospital and ambulatory surgery center (ASC) settings.

Key Features of the Catalyst Fracture System

The Catalyst Fracture System for RSA incorporates several key elements:
  • A tuberosity-specific fossa designed to maximize tuberosity contact and promote healing through a porous surface.
  • Patented tuberosity retention rails to restrict tuberosity motion post-operatively.
  • Uncemented, secure press-fit diaphyseal fixation for strong rotational stability, with cemented options available.
  • Compatibility with glenospheres and baseplates in standard, augmented, and lateralized configurations to accommodate various glenoid anatomies.

Clinical Experience and Future Availability

Dr. Matthew D. Budge from Salem, OR, who performed one of the first cases, noted the system's simplified tuberosity management and improved efficiency due to excellent diaphyseal fixation without cement or screws.
Catalyst plans a limited user release to gather additional performance data before a broader commercial launch in 2025. According to Carl O’Connell, CEO of Catalyst, the addition of the Catalyst Fracture System completes their comprehensive portfolio, allowing surgeons to treat a wider range of patients and solidifying their position in the orthopedics market.
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Reference News

[1]
Catalyst OrthoScience Announces FDA 510(k) Clearance for Shoulder Fracture System and ...
orthospinenews.com · Oct 15, 2024

Catalyst OrthoScience Inc. receives FDA 510(k) clearance for Catalyst Fracture Shoulder System, designed to treat proxim...

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