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 Osteonics Corp., Howmedica Osteonics Corp. and Smith & Nephew, Inc..
159
Total
159
Cleared
157d
Avg days
1990
Since
159 devices
Cleared
Aug 16, 1991
OMNIFIT EPF DUAL GEOMETRY ACETABULAR CUP
Osteonics Corp.
Orthopedic
60d
Cleared
Jul 24, 1991
HOWMEDICA PRECIS OSTEOLOCK FEM COMP W/HYDRO COAT
Howmedica Corp.
Orthopedic
57d
Cleared
Jul 01, 1991
OMNIFIT II EPF HIP STEM SERIES
Osteonics Corp.
Orthopedic
83d
Cleared
Jun 07, 1991
HYDROXYAPATITE COATED PROFILE(R) HIP STEM
Depuy, Inc.
Orthopedic
144d
Cleared
Mar 26, 1991
PREMIER-TOTAL(TM) HIP WITH CALCITITE(R) COATING
Intermedics Orthopedics
Orthopedic
39d
Cleared
Mar 04, 1991
APR AND APR II PRESS-FIT UNIVERSAL HIP SYSTEM
Intermedics Orthopedics
Orthopedic
66d
Cleared
Dec 20, 1990
THE OMNIFIT EPF HIP JOINT FEMORAL STEM
Osteonics Corp.
Orthopedic
428d