Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
FDA product code MEH · 158 cleared devices
Class 2
Orthopedic
- Regulation
- 21 CFR 888.3353
- Review panel
- OR
- Implant
- Yes
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1990-12-20 – 2026-08-10
MEH
2026-08-10
MEH
2025-11-05
Allure Hip Stem and Intramedullary Plugs
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MEH
2025-06-13
Mfinity Femoral System
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MEH
2025-05-22
Trivicta® Hip Stem
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MEH
2025-05-01
Resolve Modular Revision Hip Stem
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MEH
2025-03-10
Alteon® HA Femoral Stems
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MEH
2024-11-25
World Liner
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MEH
2024-10-03
Icona Hip Stem
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MEH
2024-09-13
TheRay Collared and Collarless Femoral Stem
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MEH
2024-08-01
Logical Liner; World Liner; World Knee Patella
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MEH
2024-03-08
Trivicta™ Hip Stem
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MEH
2024-01-19
DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis – MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis – MR Conditional
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MEH
2023-05-23
ACTERA™ hip system
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MEH
2023-01-13
SignaSure Dual Mobility System
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MEH
2022-08-11
Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem
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MEH
2022-08-04
Actera™ hip system
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MEH
2022-01-07
SignaSure Dual Mobility System
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MEH
2021-09-24
Encore Hip Stem
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MEH
2021-08-16
Insignia Hip Stem
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MEH
2021-05-20
Actis DuoFix Hip Prosthesis- Collarless
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MEH
2020-10-16
MUTARS Cemented Femoral Stems
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MEH
2020-09-21
World Hip Stem, World Cup, World Liner
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MEH
2020-02-04
Summit DuoFix HA Coating
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MEH
2019-03-25
MUTARS Proximal Femur Replacement System
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MEH
2018-04-11
Corin TriFit CF Hip Stem
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MEH
2018-01-19
LINK® BiMobile(TM) Dual Mobility System
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MEH
2017-08-24
Entrada™ hip stem
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MEH
2017-05-01
REDAPT Sleeved Monolithic Revision Stems
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MEH
2017-04-26
Exactech® Alteon® HA Femoral Stem
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MEH
2016-08-31
Exactech® Novation® Element Press-fit Femoral Stem
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MEH
2016-08-22
H-Max S stem
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MEH
2016-07-19
Origin Coxa Vara Hip Stem
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MEH
2016-07-19
DePuy Actis DuoFix Hip Prosthesis
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MEH
2016-06-03
Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20° Hooded Acetabular Liner
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MEH
2016-03-31
Corin TriFit TS Hip
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MEH
2013-02-01
NOVEL FIT AND FILL STEM
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MEH
2012-11-09
H-MAX S FEMORAL STEMS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS
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MEH
2012-10-15
SMITH & NEPHEW REDAPT REVISION FEMORAL SYSTEM
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MEH
2012-10-05
CORIN TRIFIT TS HIP
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MEH
2012-10-05
SMITH & NEPHEW RADIOPAQUE TRIAL NECKS
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MEH
2012-04-19
MODULAR PROXIMALLY FLUTED HIP STEM
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MEH
2012-03-16
NOVATION ELEMENT FEMORAL STEM, 12/14 COLLARLESS STANDARD/HIGH OFFSET HA COATED PRESS-FIT, SZ 8-12
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MEH
2011-12-15
MSA HIP SYSTEM
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MEH
2011-09-28
ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS
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MEH
2011-03-10
NOVEL TAPERED HIP STEM
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MEH
2011-03-04
CERAMIC FEMORAL HEAD
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MEH
2011-03-01
MSA HIP SYSTEM
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MEH
2010-12-09
PREVISION HIP SYSTEM WITH RECON RING
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MEH
2010-11-23
TRINITY ACETABULAR SYSTEM
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MEH
2010-07-15
SMITH & NEPHEW MDF MODULAR SLEEVE
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MEH
2010-04-21
SMITH & NEPHEW HIP SYSTEMS WITH HA
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MEH
2010-03-12
VESAFITCUP DOUBLE MOBILITY- HIGHCROSS HXUHMWPE LINERS
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MEH
2009-12-18
RESTORATION ADM SYSTEM X3 ACETABULAR
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MEH
2009-11-04
ABG II MODULAR HIP STEM
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MEH
2009-10-20
REJUVENATE MODULAR STEM
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MEH
2009-09-22
EXCIA TOTAL HIP SYSTEM M AN ML FEMORAL STEM
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MEH
2009-06-16
REJUVENATE MONOLITHIC SIZE 4 HIP STEM
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MEH
2009-04-07
VERSAFIT CUP DOUBLE MOBILITY SYSTEM
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MEH
2008-12-29
REJUVENATE MONOLITHIC HIP SYSTEM
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MEH
2008-07-31
MDF REVISION HIP SYSTEM
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MEH
2008-06-03
REJUVENATE MODULAR HIP SYSTEM
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MEH
2008-06-02
METHA HIP SYSTEM
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MEH
2008-05-09
METHA SHORT STEM HIP SYSTEM
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MEH
2008-05-06
EXACTECH NOVATION ELEMENT PRESS-FIT FEMORAL STEMS
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MEH
2007-10-18
RESTORATION ADM SYSTEM
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MEH
2007-07-25
CERMET III ACETABULAR CUP SYSTEM
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MEH
2006-03-22
EXCIA TOTAL HIP SYSTEM WITH U-CAP
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MEH
2006-01-13
SHORT CITATION FEMORAL STEM
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MEH
2005-12-07
SMITH & NEPHEW MODULAR HIP
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MEH
2004-12-08
BICONTACT HIP SYSTEM WITH U-CAP
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MEH
2004-11-19
SMITH & NEPHEW MODULAR HIP
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MEH
2004-10-08
FURLONG H-AC TOTAL HIP REPLACEMENT SYSTEM
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MEH
2004-06-14
CONTOUR HA COATED RECONSTRUCTION RING
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MEH
2004-06-04
EXACTECH ACUMATCH A-SERIES AND MCS ACETABULAR SHELLS AND LINERS
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MEH
2004-01-20
MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEM
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MEH
2003-10-09
ACCOLADE-J HIP STEM SERIES
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MEH
2002-10-25
ECHELON POROUS PLUS HA HIP STEMS
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MEH
2002-10-09
ACCOLADE TMZF PLUS HA 127 SIZE 0 HIP STEM
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MEH
2002-05-31
HA MALLORY/HEAD POROUS FEMORAL STEM & HA MALLORY/HEAD POROUS LATERALIZED FEMORAL STEM
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MEH
2002-05-13
SUPER SECUR-FIT HA HIP STEMS AND SUPER SECUR-FIT PLUS HA HIP STEMS
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MEH
2002-05-03
ESOP HA FEMORAL STEM
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MEH
2002-04-16
TAPERLOC POROUS FEMORAL STEM & HA TAPERLOC POROUS LATERALIZED FEMORAL STEM
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MEH
2002-03-04
ACCOLADE TMZF HA 132 DEGREE SIZE 0 HIP STEM
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MEH
2001-12-05
TRIDENT HEMISPHERICAL ACETABULAR SHELLS
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MEH
2000-12-11
SYNERGY HA COATED POROUS FEMORAL STEMS
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MEH
2000-08-17
GROSS FEMORAL COMPONENT
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MEH
2000-08-04
TRIDENT ACETABULAR SHELLS: PS-HA
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MEH
2000-04-03
BOHN FEMORAL COMPONENT
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MEH
2000-03-16
TMZF PRESS FIT HA STEM AND TMZF PRESS FIT PLUS HA STEM
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MEH
2000-02-16
ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT AND ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT WITH HYDROXYAPATITE
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MEH
2000-02-07
THE MARGRON HIP REPLACEMENT SYSTEM
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MEH
2000-02-04
ENCORE LINEAR POROUS COATED HIP WITH HA, ENCORE FOUNDATION POROUS HIP WITH HA, ENCORE REVELATION POROUS HIP WITH HA
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MEH
2000-01-21
CITATION TMZF HA STEM
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MEH
1999-10-08
HOWMEDICA OSTEONICS RESTORATION HA HIP STEM
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MEH
1999-08-13
PRECISION OSTEOLOCK FEMORAL STEMS WITH PURE-FIX HA COATING
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MEH
1999-08-06
HYDROXYAPATITE (HA) REFLECTION ACETABULAR SHELL, HYDROXYAPATITE (HA) REFLECTION INTERFIT SHELL
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MEH
1999-07-23
OSTEONICS HA-COATED DEVICES
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MEH
1999-02-18
OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS
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MEH
1999-02-04
MODULUS COMPATIBLE STABILITY (MCS)-HA TOTAL HIP SYSTEM
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MEH
1998-12-11
OSTEONICS HA GENERATION II ACETABULAR COMPONENT SYSTEM
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