MEH · Class II · 21 CFR 888.3353

FDA Product Code MEH: Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate

FDA product code MEH covers uncemented semi-constrained hip prostheses with metal bearing surfaces.

These implants rely on biological fixation — bone ingrowth or ongrowth into a porous-coated surface — rather than bone cement for long-term stability. Uncemented fixation is the preferred approach in younger, more active patients due to its potential for longer implant longevity.

MEH devices are Class II medical devices, regulated under 21 CFR 888.3353 and reviewed by the FDA Orthopedic panel.

Leading manufacturers include Signature Orthopaedics Pty, Ltd., Depuy Ireland UC and Conformis, Inc..

159
Total
159
Cleared
157d
Avg days
1990
Since
159 devices
145–159 of 159
No devices found for this product code.