3DKNEE SYSTEM

by Unknown

Orthopedic ImplantsFDA 510kOn market since 2015
78
Moderate

The 3DKNEE SYSTEM by Unknown has a safety score of 78 out of 100, placing it in the moderate-risk category. Based on FDA MAUDE data, there have been 117 adverse event reports since its introduction in 2015. With an estimated 0 units in use, the incident rate is 0 per 10,000 units. It ranks #15 out of 53 devices in the Orthopedic Implants category.

Adverse Events

117

Total reports filed with FDA MAUDE

Death Reports

0

Death reports associated with device

Incident Rate

0

Per 10,000 units in use

Recalls

0

No recalls on record

Estimated Units in Use

0

Based on market data estimates

Category Ranking

#15 of 53

In Orthopedic Implants by safety score

How This Compares

Safety Score78/100
Category Average
74
This Device
78
Best in Category
83

Important Context

Adverse event reports reflect reported incidents, not confirmed device failures. Higher numbers may indicate greater device usage, better reporting systems, or increased awareness. This data should be one factor in your research — always consult your physician.