How do Orthopaedic Devices Change After Their Initial FDA Premarket Approval?

Area of Science:

• Orthopaedic device regulation and postmarket surveillance.
• Medical device engineering and design changes.
• Regulatory science and FDA approval processes.

Background:

• The U.S. Food and Drug Administration (FDA) approves high-risk medical devices via the Premarket Approval (PMA) process, requiring clinical evidence of safety and effectiveness.
• Postmarket modifications to these devices are often approved through PMA supplements, typically without new clinical data.
• While devices cleared via the 510(k) pathway have been studied, those approved through PMA and its supplements require further investigation.

Purpose of the Study:

• To identify types of orthopaedic devices receiving FDA PMA approval.
• To quantify the number and rate of postmarket changes for these devices.
• To analyze the review tracks and types of changes approved, and assess device recalls.

Main Methods:

• A comprehensive review of all FDA-approved orthopaedic devices via the PMA pathway from January 1982 to December 2014.
• Assessment of postmarket changes, PMA supplement review tracks, types of modifications, and FDA recalls for each device.

Main Results:

• Seventy original orthopaedic devices (34 joint, 18 spinal, 18 other) received PMA approval.
• These devices experienced a median of 6.5 postmarket changes, with an increasing rate of approved changes over time.
• 22% of 765 total postmarket changes involved design or component alterations, primarily reviewed under real-time or 180-day tracks.
• Twelve devices were recalled, including two hip prostheses with high revision rates.

Conclusions:

• A limited number of orthopaedic devices undergo the rigorous FDA PMA process.
• Significant postmarket modifications occur for PMA-approved devices, potentially leading to design "drift" from original tested versions.
• Orthopaedic surgeons must be aware of these modifications and emphasize continued postmarket surveillance to mitigate patient safety risks.