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..

160
Total
160
Cleared
157d
Avg days
1990
Since
160 devices
73–96 of 160
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 31, 2002
HA MALLORY/HEAD POROUS FEMORAL STEM & HA MALLORY/HEAD POROUS LATERALIZED FEMORAL STEM
K021403
Biomet Orthopedics, Inc.
Orthopedic · 29d
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 Apr 16, 2002
TAPERLOC POROUS FEMORAL STEM & HA TAPERLOC POROUS LATERALIZED FEMORAL STEM
K020963
Biomet Orthopedics, Inc.
Orthopedic · 22d
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 Apr 03, 2000
BOHN FEMORAL COMPONENT
K000262
Biomet Manufacturing, Inc.
Orthopedic · 66d
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
Cleared Feb 07, 2000
THE MARGRON HIP REPLACEMENT SYSTEM
K992815
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
K993943
Encore Orthopedics, Inc.
Orthopedic · 77d
Cleared Jan 21, 2000
CITATION TMZF HA STEM
K993768
Howmedica Osteonics Corp.
Orthopedic · 74d
Cleared Oct 08, 1999
HOWMEDICA OSTEONICS RESTORATION HA HIP STEM
K993077
Howmedica Osteonics Corp.
Orthopedic · 24d
Cleared Aug 13, 1999
PRECISION OSTEOLOCK FEMORAL STEMS WITH PURE-FIX HA COATING
K992025
Howmedica Osteonics Corp.
Orthopedic · 58d
Cleared Aug 06, 1999
HYDROXYAPATITE (HA) REFLECTION ACETABULAR SHELL, HYDROXYAPATITE (HA) REFLECTION INTERFIT SHELL
K990666
Smith & Nephew, Inc.
Orthopedic · 157d
Cleared Jul 23, 1999
OSTEONICS HA-COATED DEVICES
K980070
Osteonics Corp.
Orthopedic · 561d
Cleared Feb 18, 1999
OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS
K990203
Osteonics Corp.
Orthopedic · 28d