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
May 25, 1995
DEPUY CDH PROSTHESIS
Depuy, Inc.
Orthopedic
176d
Cleared
Apr 10, 1995
OSTEONICS RESTORATION MONOLITHIC II HIP STEM SERIES
Osteonics Corp.
Orthopedic
192d
Cleared
Apr 10, 1995
OSTEONICS(R) RESTORATION MONOLITHIC II HIP STEM SERIES
Osteonics Corp.
Orthopedic
109d
Cleared
Mar 17, 1995
OSTEONICS(R) THREADED HA ACETABULAR SHELLS
Osteonics Corp.
Orthopedic
116d
Cleared
Mar 15, 1995
OSTEONICS SECURE-FIT AD-HA ACETABULAR COMPONENT SYSTEM
Osteonics Corp.
Orthopedic
268d
Cleared
Mar 06, 1995
RESTORATION HA ACETABULAR CUP SERIES
Osteonics Corp.
Orthopedic
203d
Cleared
Nov 02, 1994
SUMMIT TOTAL HIP SYSTEM
Kirschner Medical Corp.
Orthopedic
135d
Cleared
Jul 13, 1994
F-220 PRESS-FIT FEMORAL HIP STEM SYSTEM
Implex Corp.
Orthopedic
211d
Cleared
Mar 17, 1994
HA TI-FIT ACETABULAR AND FEMORAL COMPONENT
Smith & Nephew Richards, Inc.
Orthopedic
652d
Cleared
Feb 14, 1994
STABILITY FEMORAL PROSTHESIS W/HAP
Depuy, Inc.
Orthopedic
789d
Cleared
Nov 08, 1993
HA ANATOMIC HIP PROSTH W/TI-NIDIUM SURF HARD PROCE
Zimmer, Inc.
Orthopedic
368d
Cleared
Oct 22, 1993
CONTOUR FEMORAL HIP STEM W/HYDROAPATITE COATING
Depuy, Inc.
Orthopedic
312d
Cleared
Oct 15, 1993
H-220 PRESS-FIT ACETABULAR CUP SYSTEM
Implex Corp.
Orthopedic
312d
Cleared
May 05, 1993
HYDROXYLAPATITE INFINITY(R)
Dow Corning Wright
Orthopedic
429d
Cleared
Dec 24, 1992
PERFECTA TOTAL HIP SYSTEM, HA COATED
Orthomet, Inc.
Orthopedic
398d
Cleared
Aug 07, 1992
INTER-HA HIP PROSTHESIS
Kirschner Medical Corp.
Orthopedic
121d
Cleared
Feb 03, 1992
HYDROXYAPATITE INFINITY TROCHANTERIC MODULE
Dow Corning Wright
Orthopedic
69d
Cleared
Dec 09, 1991
HYDROXYLAPATITE COATED TI-FIT FEMORAL COMPONENT
Smith & Nephew Richards, Inc.
Orthopedic
97d
Cleared
Oct 11, 1991
HAP BIO-GROOVE TOTAL HIP PROSTHESIS (BIO-COAT)
Biomet, Inc.
Orthopedic
135d
Cleared
Oct 11, 1991
HAP BIO-GROOVE TOTAL HIP PROSTH (BIO-INTERFACES)
Biomet, Inc.
Orthopedic
135d
Cleared
Oct 04, 1991
HA MCCUTCHEN SLT HIP SYSTEM
Dow Corning Wright
Orthopedic
123d
Cleared
Oct 04, 1991
DIMENSION-HA HIP PROSTHESIS
Kirschner Medical Corp.
Orthopedic
93d
Cleared
Aug 29, 1991
HA ANATOMIC HIP PROSTH W/ TI-NIDIUM SURF HARD PROC
Zimmer, Inc.
Orthopedic
99d
Cleared
Aug 16, 1991
OMNIFIT(R) EPF DUAL GEOMTRY/RADIUS/THREAD ACETAB C
Osteonics Corp.
Orthopedic
121d