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
97–120 of 159
Cleared May 25, 1995
DEPUY CDH PROSTHESIS
K945844
Depuy, Inc.
Orthopedic · 176d
Cleared Apr 10, 1995
OSTEONICS RESTORATION MONOLITHIC II HIP STEM SERIES
K944836
Osteonics Corp.
Orthopedic · 192d
Cleared Apr 10, 1995
OSTEONICS(R) RESTORATION MONOLITHIC II HIP STEM SERIES
K946234
Osteonics Corp.
Orthopedic · 109d
Cleared Mar 17, 1995
OSTEONICS(R) THREADED HA ACETABULAR SHELLS
K945691
Osteonics Corp.
Orthopedic · 116d
Cleared Mar 15, 1995
OSTEONICS SECURE-FIT AD-HA ACETABULAR COMPONENT SYSTEM
K942900
Osteonics Corp.
Orthopedic · 268d
Cleared Mar 06, 1995
RESTORATION HA ACETABULAR CUP SERIES
K943957
Osteonics Corp.
Orthopedic · 203d
Cleared Nov 02, 1994
SUMMIT TOTAL HIP SYSTEM
K942891
Kirschner Medical Corp.
Orthopedic · 135d
Cleared Jul 13, 1994
F-220 PRESS-FIT FEMORAL HIP STEM SYSTEM
K935990
Implex Corp.
Orthopedic · 211d
Cleared Mar 17, 1994
HA TI-FIT ACETABULAR AND FEMORAL COMPONENT
K922621
Smith & Nephew Richards, Inc.
Orthopedic · 652d
Cleared Feb 14, 1994
STABILITY FEMORAL PROSTHESIS W/HAP
K915655
Depuy, Inc.
Orthopedic · 789d
Cleared Nov 08, 1993
HA ANATOMIC HIP PROSTH W/TI-NIDIUM SURF HARD PROCE
K925607
Zimmer, Inc.
Orthopedic · 368d
Cleared Oct 22, 1993
CONTOUR FEMORAL HIP STEM W/HYDROAPATITE COATING
K926299
Depuy, Inc.
Orthopedic · 312d
Cleared Oct 15, 1993
H-220 PRESS-FIT ACETABULAR CUP SYSTEM
K926134
Implex Corp.
Orthopedic · 312d
Cleared May 05, 1993
HYDROXYLAPATITE INFINITY(R)
K920969
Dow Corning Wright
Orthopedic · 429d
Cleared Dec 24, 1992
PERFECTA TOTAL HIP SYSTEM, HA COATED
K915190
Orthomet, Inc.
Orthopedic · 398d
Cleared Aug 07, 1992
INTER-HA HIP PROSTHESIS
K921672
Kirschner Medical Corp.
Orthopedic · 121d
Cleared Feb 03, 1992
HYDROXYAPATITE INFINITY TROCHANTERIC MODULE
K915350
Dow Corning Wright
Orthopedic · 69d
Cleared Dec 09, 1991
HYDROXYLAPATITE COATED TI-FIT FEMORAL COMPONENT
K913916
Smith & Nephew Richards, Inc.
Orthopedic · 97d
Cleared Oct 11, 1991
HAP BIO-GROOVE TOTAL HIP PROSTHESIS (BIO-COAT)
K912369
Biomet, Inc.
Orthopedic · 135d
Cleared Oct 11, 1991
HAP BIO-GROOVE TOTAL HIP PROSTH (BIO-INTERFACES)
K912370
Biomet, Inc.
Orthopedic · 135d
Cleared Oct 04, 1991
HA MCCUTCHEN SLT HIP SYSTEM
K912452
Dow Corning Wright
Orthopedic · 123d
Cleared Oct 04, 1991
DIMENSION-HA HIP PROSTHESIS
K912922
Kirschner Medical Corp.
Orthopedic · 93d
Cleared Aug 29, 1991
HA ANATOMIC HIP PROSTH W/ TI-NIDIUM SURF HARD PROC
K912263
Zimmer, Inc.
Orthopedic · 99d
Cleared Aug 16, 1991
OMNIFIT(R) EPF DUAL GEOMTRY/RADIUS/THREAD ACETAB C
K911728
Osteonics Corp.
Orthopedic · 121d