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
25–48 of 159
Cleared Jan 19, 2018
LINK® BiMobile(TM) Dual Mobility System
K171273
Waldemar Link GmbH & Co. KG
Orthopedic · 263d
Cleared May 01, 2017
REDAPT Sleeved Monolithic Revision Stems
K162303
Smith & Nephew, Inc.
Orthopedic · 257d
Cleared Apr 26, 2017
Exactech® Alteon® HA Femoral Stem
K162732
Exactech, Inc.
Orthopedic · 209d
Cleared Feb 01, 2013
NOVEL FIT AND FILL STEM
K122853
Howmedica Osteonics Corp.
Orthopedic · 136d
Cleared Oct 15, 2012
SMITH & NEPHEW REDAPT REVISION FEMORAL SYSTEM
K121627
Smith & Nephew, Inc.
Orthopedic · 133d
Cleared Oct 05, 2012
SMITH & NEPHEW RADIOPAQUE TRIAL NECKS
K113039
Smith & Nephew, Inc.
Orthopedic · 359d
Cleared Apr 19, 2012
MODULAR PROXIMALLY FLUTED HIP STEM
K113789
Smith & Nephew, Inc.
Orthopedic · 119d
Cleared Sep 28, 2011
ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS
K112556
Howmedica Osteonics Corp.
Orthopedic · 26d
Cleared Jul 15, 2010
SMITH & NEPHEW MDF MODULAR SLEEVE
K100481
Smith & Nephew, Inc.
Orthopedic · 147d
Cleared Apr 21, 2010
SMITH & NEPHEW HIP SYSTEMS WITH HA
K090982
Smith & Nephew, Inc.
Orthopedic · 379d
Cleared Dec 18, 2009
RESTORATION ADM SYSTEM X3 ACETABULAR
K093644
Howmedica Osteonics Corp.
Orthopedic · 23d
Cleared Nov 04, 2009
ABG II MODULAR HIP STEM
K092406
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Oct 20, 2009
REJUVENATE MODULAR STEM
K092561
Howmedica Osteonics Corp.
Orthopedic · 60d
Cleared Jun 16, 2009
REJUVENATE MONOLITHIC SIZE 4 HIP STEM
K091161
Howmedica Osteonics Corp.
Orthopedic · 56d
Cleared Dec 29, 2008
REJUVENATE MONOLITHIC HIP SYSTEM
K082892
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Jul 31, 2008
MDF REVISION HIP SYSTEM
K081124
Smith & Nephew, Inc.
Orthopedic · 101d
Cleared Jun 03, 2008
REJUVENATE MODULAR HIP SYSTEM
K081044
Howmedica Osteonics Corp.
Orthopedic · 50d
Cleared Oct 18, 2007
RESTORATION ADM SYSTEM
K072020
Howmedica Osteonics Corp.
Orthopedic · 87d
Cleared Dec 07, 2005
SMITH & NEPHEW MODULAR HIP
K052426
Smith & Nephew, Inc.
Orthopedic · 96d
Cleared Nov 19, 2004
SMITH & NEPHEW MODULAR HIP
K042127
Smith & Nephew, Inc.
Orthopedic · 105d
Cleared Jun 14, 2004
CONTOUR HA COATED RECONSTRUCTION RING
K040680
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Oct 09, 2003
ACCOLADE-J HIP STEM SERIES
K032300
Howmedica Osteonics Corp.
Orthopedic · 76d
Cleared Oct 25, 2002
ECHELON POROUS PLUS HA HIP STEMS
K023302
Smith & Nephew, Inc.
Orthopedic · 22d
Cleared Oct 09, 2002
ACCOLADE TMZF PLUS HA 127 SIZE 0 HIP STEM
K023102
Howmedica Osteonics Corp.
Orthopedic · 21d