DeviceClearance

Product code HSX— Orthopedic

BC Reflex Uni Knee System

Classification name
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Device class
Class 2
Regulation
21 CFR 888.3520
Advisory panel
Orthopedic
Total cleared
115
First cleared
Most recent

Market context for product code HSX

FDA has cleared 115 devices under product code HSX between 1977 and 2026, filed by 47 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code HSX

Adverse events under product code HSX

product code HSX
Injury
1,003
Other
1
Total
1,004

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code HSX

1–100 of 115

Data sourced from openFDA. This site is unofficial and independent of the FDA.