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
Oct 20, 2009
REJUVENATE MODULAR STEM
Howmedica Osteonics Corp.
Orthopedic
60d
Cleared
Jun 16, 2009
REJUVENATE MONOLITHIC SIZE 4 HIP STEM
Howmedica Osteonics Corp.
Orthopedic
56d
Cleared
Apr 07, 2009
VERSAFIT CUP DOUBLE MOBILITY SYSTEM
Medacta International S.A.
Orthopedic
168d
Cleared
Dec 29, 2008
REJUVENATE MONOLITHIC HIP SYSTEM
Howmedica Osteonics Corp.
Orthopedic
90d
Cleared
Jul 31, 2008
MDF REVISION HIP SYSTEM
Smith & Nephew, Inc.
Orthopedic
101d
Cleared
Jun 03, 2008
REJUVENATE MODULAR HIP SYSTEM
Howmedica Osteonics Corp.
Orthopedic
50d
Cleared
May 06, 2008
EXACTECH NOVATION ELEMENT PRESS-FIT FEMORAL STEMS
Exactech, Inc.
Orthopedic
29d
Cleared
Oct 18, 2007
RESTORATION ADM SYSTEM
Howmedica Osteonics Corp.
Orthopedic
87d
Cleared
Mar 22, 2006
EXCIA TOTAL HIP SYSTEM WITH U-CAP
Aesculap, Inc.
Orthopedic
29d
Cleared
Dec 07, 2005
SMITH & NEPHEW MODULAR HIP
Smith & Nephew, Inc.
Orthopedic
96d
Cleared
Nov 19, 2004
SMITH & NEPHEW MODULAR HIP
Smith & Nephew, Inc.
Orthopedic
105d
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 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
Feb 16, 2000
ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT AND ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT WITH HYDROXYAPATITE
Exactech, Inc.
Orthopedic
20d