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 Howmedica Osteonics Corp., Smith & Nephew, Inc. and Signature Orthopaedics Pty, Ltd..

159
Total
159
Cleared
157d
Avg days
1990
Since
159 devices
49–72 of 159
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 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 Mar 16, 2000
TMZF PRESS FIT HA STEM AND TMZF PRESS FIT PLUS HA STEM
K994366
Howmedica Osteonics Corp.
Orthopedic · 80d
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 Jan 18, 1996
PCA +15MM MODULAR FEMORAL HEAD
K955305
Howmedica Corp.
Orthopedic · 59d
Cleared May 25, 1995
DEPUY CDH PROSTHESIS
K945844
Depuy, Inc.
Orthopedic · 176d
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 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 Aug 29, 1991
HA ANATOMIC HIP PROSTH W/ TI-NIDIUM SURF HARD PROC
K912263
Zimmer, Inc.
Orthopedic · 99d
Cleared Jul 24, 1991
HOWMEDICA PRECIS OSTEOLOCK FEM COMP W/HYDRO COAT
K912395
Howmedica Corp.
Orthopedic · 57d
Cleared Jun 07, 1991
HYDROXYAPATITE COATED PROFILE(R) HIP STEM
K910156
Depuy, Inc.
Orthopedic · 144d