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
Apr 11, 2018
Corin TriFit CF Hip Stem
Corin U.S.A. Limited
Orthopedic
111d
Cleared
Jan 19, 2018
LINK® BiMobile(TM) Dual Mobility System
Waldemar Link GmbH & Co. KG
Orthopedic
263d
Cleared
Aug 24, 2017
Entrada™ hip stem
Ortho Development Corporation
Orthopedic
118d
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
Aug 31, 2016
Exactech® Novation® Element Press-fit Femoral Stem
Exactech, Inc.
Orthopedic
254d
Cleared
Aug 22, 2016
H-Max S stem
Lima Corporate S.P.A.
Orthopedic
231d
Cleared
Jul 19, 2016
DePuy Actis DuoFix Hip Prosthesis
Depuy(Ireland)
Orthopedic
109d
Cleared
Jul 19, 2016
Origin Coxa Vara Hip Stem
Signature Orthopaedics Pty, Ltd.
Orthopedic
85d
Cleared
Jun 03, 2016
Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20° Hooded Acetabular Liner
Signature Orthopaedics Pty, Ltd.
Orthopedic
217d
Cleared
Mar 31, 2016
Corin TriFit TS Hip
Corin U.S.A. Limited
Orthopedic
91d
Cleared
Oct 21, 2015
H-MAX S Femoral Hip System
Lima Corporate S.P.A.
Orthopedic
204d
Cleared
Sep 25, 2015
DePuy Actis Duofox Hip Prosthesis
DePuy Orthopaedics, Inc.
Orthopedic
177d
Cleared
Feb 01, 2013
NOVEL FIT AND FILL STEM
Howmedica Osteonics Corp.
Orthopedic
136d
Cleared
Nov 09, 2012
H-MAX S FEMORAL STEMS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS
Lima Corporate S.P.A.
Orthopedic
477d
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
Oct 05, 2012
CORIN TRIFIT TS HIP
Corin USA
Orthopedic
129d
Cleared
Apr 19, 2012
MODULAR PROXIMALLY FLUTED HIP STEM
Smith & Nephew, Inc.
Orthopedic
119d
Cleared
Mar 16, 2012
NOVATION ELEMENT FEMORAL STEM, 12/14 COLLARLESS STANDARD/HIGH OFFSET HA COATED PRESS-FIT, SZ 8-12
Exactech, Inc.
Orthopedic
127d
Cleared
Dec 15, 2011
MSA HIP SYSTEM
Global Manufacturing Technology
Orthopedic
56d
Cleared
Sep 28, 2011
ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS
Howmedica Osteonics Corp.
Orthopedic
26d
Cleared
Mar 10, 2011
NOVEL TAPERED HIP STEM
Stryker Corp.
Orthopedic
104d
Cleared
Mar 04, 2011
CERAMIC FEMORAL HEAD
United Orthopedic Corp.
Orthopedic
95d