DeviceClearance

Product code KWI— Orthopedic

RADIAL HEAD IMPLANT

Classification name
Prosthesis, Elbow, Hemi-, Radial, Polymer
Device class
Class 2
Regulation
21 CFR 888.3170
Advisory panel
Orthopedic
Total cleared
34
First cleared
Most recent

Market context for product code KWI

FDA has cleared 34 devices under product code KWI between 1989 and 2026, filed by 23 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 KWI

Adverse events under product code KWI

product code KWI
Injury
490
Total
490

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 KWI

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