MEH · Class II · 21 CFR 888.3353

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
49–72 of 159
Cleared Oct 20, 2009
REJUVENATE MODULAR STEM
K092561
Howmedica Osteonics Corp.
Orthopedic · 60d
Cleared Jun 16, 2009
REJUVENATE MONOLITHIC SIZE 4 HIP STEM
K091161
Howmedica Osteonics Corp.
Orthopedic · 56d
Cleared Apr 07, 2009
VERSAFIT CUP DOUBLE MOBILITY SYSTEM
K083116
Medacta International S.A.
Orthopedic · 168d
Cleared Dec 29, 2008
REJUVENATE MONOLITHIC HIP SYSTEM
K082892
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Jul 31, 2008
MDF REVISION HIP SYSTEM
K081124
Smith & Nephew, Inc.
Orthopedic · 101d
Cleared Jun 03, 2008
REJUVENATE MODULAR HIP SYSTEM
K081044
Howmedica Osteonics Corp.
Orthopedic · 50d
Cleared May 06, 2008
EXACTECH NOVATION ELEMENT PRESS-FIT FEMORAL STEMS
K080980
Exactech, Inc.
Orthopedic · 29d
Cleared Oct 18, 2007
RESTORATION ADM SYSTEM
K072020
Howmedica Osteonics Corp.
Orthopedic · 87d
Cleared Mar 22, 2006
EXCIA TOTAL HIP SYSTEM WITH U-CAP
K060437
Aesculap, Inc.
Orthopedic · 29d
Cleared Dec 07, 2005
SMITH & NEPHEW MODULAR HIP
K052426
Smith & Nephew, Inc.
Orthopedic · 96d
Cleared Nov 19, 2004
SMITH & NEPHEW MODULAR HIP
K042127
Smith & Nephew, Inc.
Orthopedic · 105d
Cleared Jun 14, 2004
CONTOUR HA COATED RECONSTRUCTION RING
K040680
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Jun 04, 2004
EXACTECH ACUMATCH A-SERIES AND MCS ACETABULAR SHELLS AND LINERS
K040613
Exactech, Inc.
Orthopedic · 87d
Cleared Oct 09, 2003
ACCOLADE-J HIP STEM SERIES
K032300
Howmedica Osteonics Corp.
Orthopedic · 76d
Cleared Oct 25, 2002
ECHELON POROUS PLUS HA HIP STEMS
K023302
Smith & Nephew, Inc.
Orthopedic · 22d
Cleared Oct 09, 2002
ACCOLADE TMZF PLUS HA 127 SIZE 0 HIP STEM
K023102
Howmedica Osteonics Corp.
Orthopedic · 21d
Cleared May 13, 2002
SUPER SECUR-FIT HA HIP STEMS AND SUPER SECUR-FIT PLUS HA HIP STEMS
K020615
Howmedica Osteonics Corp.
Orthopedic · 77d
Cleared Mar 04, 2002
ACCOLADE TMZF HA 132 DEGREE SIZE 0 HIP STEM
K020572
Howmedica Osteonics Corp.
Orthopedic · 11d
Cleared Dec 05, 2001
TRIDENT HEMISPHERICAL ACETABULAR SHELLS
K013676
Howmedica Osteonics Corp.
Orthopedic · 28d
Cleared Dec 11, 2000
SYNERGY HA COATED POROUS FEMORAL STEMS
K002996
Smith & Nephew, Inc.
Orthopedic · 77d
Cleared Aug 17, 2000
GROSS FEMORAL COMPONENT
K001580
Biomet, Inc.
Orthopedic · 87d
Cleared Aug 04, 2000
TRIDENT ACETABULAR SHELLS: PS-HA
K001448
Howmedica Osteonics Corp.
Orthopedic · 87d
Cleared Mar 16, 2000
TMZF PRESS FIT HA STEM AND TMZF PRESS FIT PLUS HA STEM
K994366
Howmedica Osteonics Corp.
Orthopedic · 80d
Cleared Feb 16, 2000
ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT AND ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT WITH HYDROXYAPATITE
K000242
Exactech, Inc.
Orthopedic · 20d