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
Cleared
Jan 19, 2018
LINK® BiMobile(TM) Dual Mobility System
Waldemar Link GmbH & Co. KG
Orthopedic
263d
Cleared
May 01, 2017
REDAPT Sleeved Monolithic Revision Stems
Smith & Nephew, Inc.
Orthopedic
257d
Cleared
Apr 26, 2017
Exactech® Alteon® HA Femoral Stem
Exactech, Inc.
Orthopedic
209d
Cleared
Feb 01, 2013
NOVEL FIT AND FILL STEM
Howmedica Osteonics Corp.
Orthopedic
136d
Cleared
Oct 15, 2012
SMITH & NEPHEW REDAPT REVISION FEMORAL SYSTEM
Smith & Nephew, Inc.
Orthopedic
133d
Cleared
Oct 05, 2012
SMITH & NEPHEW RADIOPAQUE TRIAL NECKS
Smith & Nephew, Inc.
Orthopedic
359d
Cleared
Apr 19, 2012
MODULAR PROXIMALLY FLUTED HIP STEM
Smith & Nephew, Inc.
Orthopedic
119d
Cleared
Sep 28, 2011
ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS
Howmedica Osteonics Corp.
Orthopedic
26d
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
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
Jun 16, 2009
REJUVENATE MONOLITHIC SIZE 4 HIP STEM
Howmedica Osteonics Corp.
Orthopedic
56d
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
Oct 18, 2007
RESTORATION ADM SYSTEM
Howmedica Osteonics Corp.
Orthopedic
87d
Cleared
Dec 07, 2005
SMITH & NEPHEW MODULAR HIP
Smith & Nephew, Inc.
Orthopedic
96d
Cleared
Nov 19, 2004
SMITH & NEPHEW MODULAR HIP
Smith & Nephew, Inc.
Orthopedic
105d
Cleared
Jun 14, 2004
CONTOUR HA COATED RECONSTRUCTION RING
Smith & Nephew, Inc.
Orthopedic
90d
Cleared
Oct 09, 2003
ACCOLADE-J HIP STEM SERIES
Howmedica Osteonics Corp.
Orthopedic
76d
Cleared
Oct 25, 2002
ECHELON POROUS PLUS HA HIP STEMS
Smith & Nephew, Inc.
Orthopedic
22d
Cleared
Oct 09, 2002
ACCOLADE TMZF PLUS HA 127 SIZE 0 HIP STEM
Howmedica Osteonics Corp.
Orthopedic
21d