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 Howmedica Osteonics Corp., Smith & Nephew, Inc. and Signature Orthopaedics Pty, Ltd..
159
Total
159
Cleared
157d
Avg days
1990
Since
159 devices
Cleared
May 13, 2002
SUPER SECUR-FIT HA HIP STEMS AND SUPER SECUR-FIT PLUS HA HIP STEMS
Howmedica Osteonics Corp.
Orthopedic
77d
Cleared
Mar 04, 2002
ACCOLADE TMZF HA 132 DEGREE SIZE 0 HIP STEM
Howmedica Osteonics Corp.
Orthopedic
11d
Cleared
Dec 05, 2001
TRIDENT HEMISPHERICAL ACETABULAR SHELLS
Howmedica Osteonics Corp.
Orthopedic
28d
Cleared
Dec 11, 2000
SYNERGY HA COATED POROUS FEMORAL STEMS
Smith & Nephew, Inc.
Orthopedic
77d
Cleared
Aug 17, 2000
GROSS FEMORAL COMPONENT
Biomet, Inc.
Orthopedic
87d
Cleared
Aug 04, 2000
TRIDENT ACETABULAR SHELLS: PS-HA
Howmedica Osteonics Corp.
Orthopedic
87d
Cleared
Mar 16, 2000
TMZF PRESS FIT HA STEM AND TMZF PRESS FIT PLUS HA STEM
Howmedica Osteonics Corp.
Orthopedic
80d
Cleared
Jan 21, 2000
CITATION TMZF HA STEM
Howmedica Osteonics Corp.
Orthopedic
74d
Cleared
Oct 08, 1999
HOWMEDICA OSTEONICS RESTORATION HA HIP STEM
Howmedica Osteonics Corp.
Orthopedic
24d
Cleared
Aug 13, 1999
PRECISION OSTEOLOCK FEMORAL STEMS WITH PURE-FIX HA COATING
Howmedica Osteonics Corp.
Orthopedic
58d
Cleared
Aug 06, 1999
HYDROXYAPATITE (HA) REFLECTION ACETABULAR SHELL, HYDROXYAPATITE (HA) REFLECTION INTERFIT SHELL
Smith & Nephew, Inc.
Orthopedic
157d
Cleared
Jan 18, 1996
PCA +15MM MODULAR FEMORAL HEAD
Howmedica Corp.
Orthopedic
59d
Cleared
May 25, 1995
DEPUY CDH PROSTHESIS
Depuy, Inc.
Orthopedic
176d
Cleared
Feb 14, 1994
STABILITY FEMORAL PROSTHESIS W/HAP
Depuy, Inc.
Orthopedic
789d
Cleared
Nov 08, 1993
HA ANATOMIC HIP PROSTH W/TI-NIDIUM SURF HARD PROCE
Zimmer, Inc.
Orthopedic
368d
Cleared
Oct 22, 1993
CONTOUR FEMORAL HIP STEM W/HYDROAPATITE COATING
Depuy, Inc.
Orthopedic
312d
Cleared
Oct 11, 1991
HAP BIO-GROOVE TOTAL HIP PROSTHESIS (BIO-COAT)
Biomet, Inc.
Orthopedic
135d
Cleared
Oct 11, 1991
HAP BIO-GROOVE TOTAL HIP PROSTH (BIO-INTERFACES)
Biomet, Inc.
Orthopedic
135d
Cleared
Aug 29, 1991
HA ANATOMIC HIP PROSTH W/ TI-NIDIUM SURF HARD PROC
Zimmer, Inc.
Orthopedic
99d
Cleared
Jul 24, 1991
HOWMEDICA PRECIS OSTEOLOCK FEM COMP W/HYDRO COAT
Howmedica Corp.
Orthopedic
57d
Cleared
Jun 07, 1991
HYDROXYAPATITE COATED PROFILE(R) HIP STEM
Depuy, Inc.
Orthopedic
144d