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
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
Cleared
Feb 04, 1999
MODULUS COMPATIBLE STABILITY (MCS)-HA TOTAL HIP SYSTEM
Exactech, Inc.
Orthopedic
15d
Cleared
Dec 11, 1998
OSTEONICS HA GENERATION II ACETABULAR COMPONENT SYSTEM
Osteonics Corp.
Orthopedic
77d
Cleared
Dec 02, 1998
OSTEONICS RESTORATION HA HIP STEMS
Osteonics Corp.
Orthopedic
30d
Cleared
Jul 09, 1998
OSTEONICS OMNIFIT HA HIP STEM SERIES, OSTEONICS SECUR-FIT HA HIP STEM SERIES, OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS
Osteonics Corp.
Orthopedic
29d
Cleared
May 27, 1998
OSTEONICS ANTEVERTED NECK HA HIP STEMS
Osteonics Corp.
Orthopedic
89d
Cleared
Oct 01, 1997
DISTALLY FIXED HIP STEM
Sulzer Orthopedics, Inc.
Orthopedic
156d
Cleared
May 22, 1997
OSTEONICS ACETABULAR WEDGE SYSTEM
Osteonics Corp.
Orthopedic
35d
Cleared
Apr 22, 1997
OSTEONICS NORMALIZED AD-HA ACETABULAR COMPONENT SYSTEM
Osteonics Corp.
Orthopedic
78d
Cleared
Dec 19, 1996
OSTEONICS MODULAR ACETABULAR CUP (HA-COATED VERSION)
Osteonics Corp.
Orthopedic
78d
Cleared
Apr 25, 1996
APR HIP SYS W/CAL-COATED CAN STR TITANIUM (CSTI)
Intermedics Orthopedics
Orthopedic
211d
Cleared
Jan 18, 1996
PCA +15MM MODULAR FEMORAL HEAD
Howmedica Corp.
Orthopedic
59d
Cleared
Jan 17, 1996
OSTEONICS SECUR-FIT HA PLUS HIP STEM SERIES
Osteonics Corp.
Orthopedic
289d
Cleared
Nov 22, 1995
OSTEONICS SECUR-FIT HA PSL EXTRA ACETABULAR COMPONENT SYSTEM
Osteonics Corp.
Orthopedic
86d
Cleared
Sep 06, 1995
OSTEONICS RESTORATION MONOLITHIC II SLOTTED HIP STEM SERIES
Osteonics Corp.
Orthopedic
148d
Cleared
Sep 01, 1995
OSTEONICS RESTORATION MONOLITHIC II HIP STEM SERIES
Osteonics Corp.
Orthopedic
129d
Cleared
Aug 09, 1995
OSTEONICS RESTORATION MONOLITHIC HIP STEM
Osteonics Corp.
Orthopedic
156d
Cleared
Jun 06, 1995
OSTEONICS OMNIFIT AD-HA HIP STEM SERIES
Osteonics Corp.
Orthopedic
442d