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 Osteonics Corp., Howmedica Osteonics Corp. and Smith & Nephew, Inc..

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 Aug 31, 2016
Exactech® Novation® Element Press-fit Femoral Stem
K153649
Exactech, Inc.
Orthopedic · 254d
Cleared Aug 22, 2016
H-Max S stem
K160011
Lima Corporate S.P.A.
Orthopedic · 231d
Cleared Jul 19, 2016
Origin Coxa Vara Hip Stem
K161155
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
K153131
Signature Orthopaedics Pty, Ltd.
Orthopedic · 217d
Cleared Oct 21, 2015
H-MAX S Femoral Hip System
K150855
Lima Corporate S.P.A.
Orthopedic · 204d
Cleared Sep 25, 2015
DePuy Actis Duofox Hip Prosthesis
K150862
DePuy Orthopaedics, Inc.
Orthopedic · 177d
Cleared Feb 01, 2013
NOVEL FIT AND FILL STEM
K122853
Howmedica Osteonics Corp.
Orthopedic · 136d
Cleared Nov 09, 2012
H-MAX S FEMORAL STEMS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS
K112091
Lima Corporate S.P.A.
Orthopedic · 477d
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 Oct 05, 2012
CORIN TRIFIT TS HIP
K121563
Corin USA
Orthopedic · 129d
Cleared Apr 19, 2012
MODULAR PROXIMALLY FLUTED HIP STEM
K113789
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
K113320
Exactech, Inc.
Orthopedic · 127d
Cleared Sep 28, 2011
ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS
K112556
Howmedica Osteonics Corp.
Orthopedic · 26d
Cleared Mar 10, 2011
NOVEL TAPERED HIP STEM
K103479
Stryker Corp.
Orthopedic · 104d
Cleared Nov 23, 2010
TRINITY ACETABULAR SYSTEM
K093472
Corin USA
Orthopedic · 382d
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 Mar 12, 2010
VESAFITCUP DOUBLE MOBILITY- HIGHCROSS HXUHMWPE LINERS
K092265
Medacta International S.A.
Orthopedic · 226d
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