Shoulder arthroplasty device clearance: an ancestral network analysis.

Area of Science:

• Orthopedic Surgery
• Biomedical Engineering
• Regulatory Science

Background:

• The U.S. Food and Drug Administration (FDA) regulates medical devices, with most shoulder arthroplasty devices cleared via the 510(k) pathway.
• This pathway requires demonstrating "substantial equivalence" to a predicate device, raising questions about long-term safety and design evolution.

Purpose of the Study:

• To map the interconnected network of shoulder arthroplasty devices approved through the FDA 510(k) process.
• To identify equivalency links between current devices and those later recalled for design-related issues.

Main Methods:

• Analyzed the FDA 510(k) database for shoulder arthroplasty devices marketed from 1976 to 2021.
• Constructed an ancestral genealogy network using predicate information for devices cleared between 2020-2021.
• Assessed FDA design recalls and calculated the number of descendant devices for each recalled implant.

Main Results:

• Of 476 shoulder arthroplasty devices cleared since 1976, 80 (16.8%) were recalled, with 10 due to design flaws.
• Among the 29 most recently cleared devices (2020-2021), 16 (55.2%) used predicates that were later withdrawn for design failures.

Conclusions:

• Shoulder arthroplasty devices form a complex network linked by FDA 510(k) approvals dating back to 1976.
• Despite design and material changes, many modern devices claim predicates based on recalled prostheses, indicating potential systemic issues.