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..
160
Total
160
Cleared
157d
Avg days
1990
Since
160 devices
Cleared
Dec 09, 2010
PREVISION HIP SYSTEM WITH RECON RING
Aesculap Implant Systems, LLC
Orthopedic
106d
Cleared
Nov 23, 2010
TRINITY ACETABULAR SYSTEM
Corin USA
Orthopedic
382d
Cleared
Jul 15, 2010
SMITH & NEPHEW MDF MODULAR SLEEVE
Smith & Nephew, Inc.
Orthopedic
147d
Cleared
Apr 21, 2010
SMITH & NEPHEW HIP SYSTEMS WITH HA
Smith & Nephew, Inc.
Orthopedic
379d
Cleared
Mar 12, 2010
VESAFITCUP DOUBLE MOBILITY- HIGHCROSS HXUHMWPE LINERS
Medacta International S.A.
Orthopedic
226d
Cleared
Dec 18, 2009
RESTORATION ADM SYSTEM X3 ACETABULAR
Howmedica Osteonics Corp.
Orthopedic
23d
Cleared
Nov 04, 2009
ABG II MODULAR HIP STEM
Howmedica Osteonics Corp.
Orthopedic
90d
Cleared
Oct 20, 2009
REJUVENATE MODULAR STEM
Howmedica Osteonics Corp.
Orthopedic
60d
Cleared
Sep 22, 2009
EXCIA TOTAL HIP SYSTEM M AN ML FEMORAL STEM
Aesculap Implant Systems, Inc.
Orthopedic
69d
Cleared
Jun 16, 2009
REJUVENATE MONOLITHIC SIZE 4 HIP STEM
Howmedica Osteonics Corp.
Orthopedic
56d
Cleared
Apr 07, 2009
VERSAFIT CUP DOUBLE MOBILITY SYSTEM
Medacta International S.A.
Orthopedic
168d
Cleared
Dec 29, 2008
REJUVENATE MONOLITHIC HIP SYSTEM
Howmedica Osteonics Corp.
Orthopedic
90d
Cleared
Jul 31, 2008
MDF REVISION HIP SYSTEM
Smith & Nephew, Inc.
Orthopedic
101d
Cleared
Jun 03, 2008
REJUVENATE MODULAR HIP SYSTEM
Howmedica Osteonics Corp.
Orthopedic
50d
Cleared
Jun 02, 2008
METHA HIP SYSTEM
Aesculap Implant Systems, Inc.
Orthopedic
327d
Cleared
May 09, 2008
METHA SHORT STEM HIP SYSTEM
Aesculap Implant System, Inc.
Orthopedic
67d
Cleared
May 06, 2008
EXACTECH NOVATION ELEMENT PRESS-FIT FEMORAL STEMS
Exactech, Inc.
Orthopedic
29d
Cleared
Oct 18, 2007
RESTORATION ADM SYSTEM
Howmedica Osteonics Corp.
Orthopedic
87d
Cleared
Mar 22, 2006
EXCIA TOTAL HIP SYSTEM WITH U-CAP
Aesculap, Inc.
Orthopedic
29d
Cleared
Jan 13, 2006
SHORT CITATION FEMORAL STEM
Stryker Orthopaedics
Orthopedic
25d
Cleared
Dec 07, 2005
SMITH & NEPHEW MODULAR HIP
Smith & Nephew, Inc.
Orthopedic
96d
Cleared
Dec 08, 2004
BICONTACT HIP SYSTEM WITH U-CAP
Aesculap
Orthopedic
30d
Cleared
Nov 19, 2004
SMITH & NEPHEW MODULAR HIP
Smith & Nephew, Inc.
Orthopedic
105d
Cleared
Oct 08, 2004
FURLONG H-AC TOTAL HIP REPLACEMENT SYSTEM
Jri Manufacturing, Ltd.
Orthopedic
141d