DeviceClearance

Product code MEH— Orthopedic

Icona Hip Stem

Classification name
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Device class
Class 2
Regulation
21 CFR 888.3353
Advisory panel
Orthopedic
Total cleared
160
First cleared
Most recent

Market context for product code MEH

FDA has cleared 160 devices under product code MEH between 1990 and 2026, filed by 58 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 MEH

Adverse events under product code MEH

product code MEH
Injury
2,021
Total
2,021

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 MEH

1–100 of 160

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