FDA Approves Shock Absorber You Can Actually Implant in Your Knee
Published Date: 6/29/2026
Rule
Summary
The FDA is officially classifying the medial knee implanted shock absorber as a Class II device, meaning it has special safety rules but fewer hurdles than the strictest category. This change helps patients get access to this innovative knee device faster and with confidence in its safety. The new classification is effective June 29, 2026, and could save time and money for makers and users alike.
Analyzed Economic Effects
3 provisions identified: 2 benefits, 0 costs, 1 mixed.
Medial Knee Shock Absorber Now Class II
The FDA classified the medial knee implanted shock absorber as a Class II device with special controls, effective June 29, 2026 (classification applicable April 10, 2023). FDA says this reduces regulatory burdens and is intended to enhance patient access and speed availability of this knee implant.
Manufacturers Must Use 510(k) Pathway
The medial knee implanted shock absorber is subject to premarket notification under section 510(k), meaning device sponsors must submit a 510(k) to market this Class II device unless FDA later exempts it. FDA also notes a De Novo-classified device can serve as a predicate for future 510(k) submissions.
Required Testing, Training, and Labeling Controls
FDA codified special controls for the device that require: clinical data showing improved knee function and relevant adverse events; non-clinical performance testing (mechanical function, durability, fretting/corrosion, static strength, wear, fatigue, worst-case range of motion); biocompatibility; sterility and pyrogenicity data; reprocessing validation for reusable components; shelf-life demonstration; a training program for safe implantation; and labeling that includes validated reprocessing instructions and a shelf life.
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