FDA Product Code HXA: Prosthesis, Tendon, Passive
Leading manufacturers include Askorn Medical.
FDA 510(k) Cleared Prosthesis, Tendon, Passive Devices (Product Code HXA)
About Product Code HXA - Regulatory Context
510(k) Submission Activity
11 total 510(k) submissions under product code HXA since 1978, with 11 receiving FDA clearance (average review time: 103 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under HXA have taken an average of 63 days to reach a decision - down from 107 days historically, suggesting improved FDA processing for this classification.
HXA devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →