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..
160
Total
160
Cleared
157d
Avg days
1990
Since
160 devices
Cleared
Jun 14, 2004
CONTOUR HA COATED RECONSTRUCTION RING
Smith & Nephew, Inc.
Orthopedic
90d
Cleared
Jun 04, 2004
EXACTECH ACUMATCH A-SERIES AND MCS ACETABULAR SHELLS AND LINERS
Exactech, Inc.
Orthopedic
87d
Cleared
Oct 09, 2003
ACCOLADE-J HIP STEM SERIES
Howmedica Osteonics Corp.
Orthopedic
76d
Cleared
Oct 25, 2002
ECHELON POROUS PLUS HA HIP STEMS
Smith & Nephew, Inc.
Orthopedic
22d
Cleared
Oct 09, 2002
ACCOLADE TMZF PLUS HA 127 SIZE 0 HIP STEM
Howmedica Osteonics Corp.
Orthopedic
21d
Cleared
May 31, 2002
HA MALLORY/HEAD POROUS FEMORAL STEM & HA MALLORY/HEAD POROUS LATERALIZED FEMORAL STEM
Biomet Orthopedics, Inc.
Orthopedic
29d
Cleared
May 13, 2002
SUPER SECUR-FIT HA HIP STEMS AND SUPER SECUR-FIT PLUS HA HIP STEMS
Howmedica Osteonics Corp.
Orthopedic
77d
Cleared
Apr 16, 2002
TAPERLOC POROUS FEMORAL STEM & HA TAPERLOC POROUS LATERALIZED FEMORAL STEM
Biomet Orthopedics, Inc.
Orthopedic
22d
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
Apr 03, 2000
BOHN FEMORAL COMPONENT
Biomet Manufacturing, Inc.
Orthopedic
66d
Cleared
Mar 16, 2000
TMZF PRESS FIT HA STEM AND TMZF PRESS FIT PLUS HA STEM
Howmedica Osteonics Corp.
Orthopedic
80d
Cleared
Feb 16, 2000
ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT AND ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT WITH HYDROXYAPATITE
Exactech, Inc.
Orthopedic
20d
Cleared
Feb 07, 2000
THE MARGRON HIP REPLACEMENT SYSTEM
Portland Orthopaedics Pty. , Ltd.
Orthopedic
171d
Cleared
Feb 04, 2000
ENCORE LINEAR POROUS COATED HIP WITH HA, ENCORE FOUNDATION POROUS HIP WITH HA, ENCORE REVELATION POROUS HIP WITH HA
Encore Orthopedics, Inc.
Orthopedic
77d
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
Jul 23, 1999
OSTEONICS HA-COATED DEVICES
Osteonics Corp.
Orthopedic
561d
Cleared
Feb 18, 1999
OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS
Osteonics Corp.
Orthopedic
28d