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..
FDA 510(k) Cleared Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate Devices (Product Code MEH)
About Product Code MEH - Regulatory Context
510(k) Submission Activity
159 total 510(k) submissions under product code MEH since 1990, with 159 receiving FDA clearance (average review time: 157 days).
Submission volume has increased in recent years - 9 submissions in the last 24 months compared to 6 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under MEH have taken an average of 116 days to reach a decision - down from 159 days historically, suggesting improved FDA processing for this classification.
MEH devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →