DeviceClearance

Product code KWY— Orthopedic

CORIN BIPOLAR PROSTHESIS

Classification name
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Device class
Class 2
Regulation
21 CFR 888.3390
Advisory panel
Orthopedic
Total cleared
99
First cleared
Most recent

Market context for product code KWY

FDA has cleared 99 devices under product code KWY between 1978 and 2026, filed by 63 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 KWY

Adverse events under product code KWY

product code KWY
Death
3
Injury
2,049
Total
2,052

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 KWY

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