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
73–96 of 159
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
Cleared Feb 04, 1999
MODULUS COMPATIBLE STABILITY (MCS)-HA TOTAL HIP SYSTEM
K990197
Exactech, Inc.
Orthopedic · 15d
Cleared Dec 11, 1998
OSTEONICS HA GENERATION II ACETABULAR COMPONENT SYSTEM
K983382
Osteonics Corp.
Orthopedic · 77d
Cleared Dec 02, 1998
OSTEONICS RESTORATION HA HIP STEMS
K983870
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
K982032
Osteonics Corp.
Orthopedic · 29d
Cleared May 27, 1998
OSTEONICS ANTEVERTED NECK HA HIP STEMS
K980766
Osteonics Corp.
Orthopedic · 89d
Cleared Oct 01, 1997
DISTALLY FIXED HIP STEM
K971523
Sulzer Orthopedics, Inc.
Orthopedic · 156d
Cleared May 22, 1997
OSTEONICS ACETABULAR WEDGE SYSTEM
K971422
Osteonics Corp.
Orthopedic · 35d
Cleared Apr 22, 1997
OSTEONICS NORMALIZED AD-HA ACETABULAR COMPONENT SYSTEM
K970394
Osteonics Corp.
Orthopedic · 78d
Cleared Dec 19, 1996
OSTEONICS MODULAR ACETABULAR CUP (HA-COATED VERSION)
K963959
Osteonics Corp.
Orthopedic · 78d
Cleared Apr 25, 1996
APR HIP SYS W/CAL-COATED CAN STR TITANIUM (CSTI)
K954800
Intermedics Orthopedics
Orthopedic · 211d
Cleared Jan 18, 1996
PCA +15MM MODULAR FEMORAL HEAD
K955305
Howmedica Corp.
Orthopedic · 59d
Cleared Jan 17, 1996
OSTEONICS SECUR-FIT HA PLUS HIP STEM SERIES
K951517
Osteonics Corp.
Orthopedic · 289d
Cleared Nov 22, 1995
OSTEONICS SECUR-FIT HA PSL EXTRA ACETABULAR COMPONENT SYSTEM
K954023
Osteonics Corp.
Orthopedic · 86d
Cleared Sep 06, 1995
OSTEONICS RESTORATION MONOLITHIC II SLOTTED HIP STEM SERIES
K951671
Osteonics Corp.
Orthopedic · 148d
Cleared Sep 01, 1995
OSTEONICS RESTORATION MONOLITHIC II HIP STEM SERIES
K951932
Osteonics Corp.
Orthopedic · 129d
Cleared Aug 09, 1995
OSTEONICS RESTORATION MONOLITHIC HIP STEM
K951291
Osteonics Corp.
Orthopedic · 156d
Cleared Jun 06, 1995
OSTEONICS OMNIFIT AD-HA HIP STEM SERIES
K941366
Osteonics Corp.
Orthopedic · 442d