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..

160
Total
160
Cleared
157d
Avg days
1990
Since
160 devices
49–72 of 160
Cleared Dec 09, 2010
PREVISION HIP SYSTEM WITH RECON RING
K102424
Aesculap Implant Systems, LLC
Orthopedic · 106d
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
Cleared Oct 20, 2009
REJUVENATE MODULAR STEM
K092561
Howmedica Osteonics Corp.
Orthopedic · 60d
Cleared Sep 22, 2009
EXCIA TOTAL HIP SYSTEM M AN ML FEMORAL STEM
K092143
Aesculap Implant Systems, Inc.
Orthopedic · 69d
Cleared Jun 16, 2009
REJUVENATE MONOLITHIC SIZE 4 HIP STEM
K091161
Howmedica Osteonics Corp.
Orthopedic · 56d
Cleared Apr 07, 2009
VERSAFIT CUP DOUBLE MOBILITY SYSTEM
K083116
Medacta International S.A.
Orthopedic · 168d
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 Jun 02, 2008
METHA HIP SYSTEM
K071916
Aesculap Implant Systems, Inc.
Orthopedic · 327d
Cleared May 09, 2008
METHA SHORT STEM HIP SYSTEM
K080584
Aesculap Implant System, Inc.
Orthopedic · 67d
Cleared May 06, 2008
EXACTECH NOVATION ELEMENT PRESS-FIT FEMORAL STEMS
K080980
Exactech, Inc.
Orthopedic · 29d
Cleared Oct 18, 2007
RESTORATION ADM SYSTEM
K072020
Howmedica Osteonics Corp.
Orthopedic · 87d
Cleared Mar 22, 2006
EXCIA TOTAL HIP SYSTEM WITH U-CAP
K060437
Aesculap, Inc.
Orthopedic · 29d
Cleared Jan 13, 2006
SHORT CITATION FEMORAL STEM
K053528
Stryker Orthopaedics
Orthopedic · 25d
Cleared Dec 07, 2005
SMITH & NEPHEW MODULAR HIP
K052426
Smith & Nephew, Inc.
Orthopedic · 96d
Cleared Dec 08, 2004
BICONTACT HIP SYSTEM WITH U-CAP
K043079
Aesculap
Orthopedic · 30d
Cleared Nov 19, 2004
SMITH & NEPHEW MODULAR HIP
K042127
Smith & Nephew, Inc.
Orthopedic · 105d
Cleared Oct 08, 2004
FURLONG H-AC TOTAL HIP REPLACEMENT SYSTEM
K041353
Jri Manufacturing, Ltd.
Orthopedic · 141d