FDA Product Code LPH: Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Under FDA product code LPH, semi-constrained hip prostheses with metal and polymer bearing surfaces are cleared for total hip arthroplasty.
These implants use a metal femoral head articulating against a polymer — typically ultra-high molecular weight polyethylene — acetabular liner. Metal-on-polymer is the most established bearing couple in hip replacement, with decades of clinical data supporting its performance.
LPH devices are Class II medical devices, regulated under 21 CFR 888.3358 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include Zimmer, Inc., Biomet, Inc. and DePuy Orthopaedics, Inc..
564
Total
564
Cleared
152d
Avg days
1984
Since
564 devices
Cleared
May 08, 1996
HEMISPHERE ACETABULAR CUP
Ortho Development Corp.
Orthopedic
82d
Cleared
May 02, 1996
22 MM COCR HEAD & POLYETHLENE LINER
Stelkast Company
Orthopedic
107d
Cleared
Mar 27, 1996
MODULAR ACETABULAR SHELL II
Intermedics Orthopedics
Orthopedic
100d
Cleared
Mar 27, 1996
DEPUY POROCOAT HPS II HIP PROSTHESIS W/ARTICUL-EZE TAPER
Depuy, Inc.
Orthopedic
71d
Cleared
Mar 22, 1996
HOWMEDICA ASYMMETRIC STEM FEMORAL COMPONENT
Howmedica Corp.
Orthopedic
87d
Cleared
Feb 26, 1996
ARTHOPOR I & II ACETABULAR CUP/ARTHOPOR II OBLONG ACETABULAR CUP
Joint Medical Products Corp.
Orthopedic
84d
Cleared
Feb 09, 1996
NEXFLEX FEMORAL STEM, STANDARD DESIGN
Nexmed, Inc.
Orthopedic
88d
Cleared
Feb 01, 1996
DEPUY VISION AML HIP PROTHESIS
Depuy, Inc.
Orthopedic
177d
Cleared
Feb 01, 1996
DEPUY VISION SOLUTION HIP PROSTHESIS
Depuy, Inc.
Orthopedic
177d
Cleared
Jan 31, 1996
RIM FLARE ACETABULAR COMPONENT
Intermedics Orthopedics
Orthopedic
90d
Cleared
Jan 30, 1996
MICRO-SEAL ACETABULAR SYSTEM
Whiteside Instruments
Orthopedic
76d
Cleared
Jan 22, 1996
BETA HIP PROSTHESIS
Zimmer, Inc.
Orthopedic
189d
Cleared
Jan 22, 1996
S-ROM FEMORAL HIP STEM - SIZE 14 X 8
Joint Medical Products Corp.
Orthopedic
87d
Cleared
Jan 17, 1996
TRILOGY ACETABULAR COMPONENT 7MM OFFSET
Zimmer, Inc.
Orthopedic
97d
Cleared
Jan 17, 1996
DEPUY ADVANTAGE HIP FEMORAL PROSTHESIS WITH POROCOAT
Depuy, Inc.
Orthopedic
90d
Cleared
Dec 11, 1995
A-B ACETABULAR COMPONENT
Biomet, Inc.
Orthopedic
81d
Cleared
Dec 04, 1995
PROFORM POROUS BEADED FEMORAL STEM
Stelkast Company
Orthopedic
70d
Cleared
Nov 30, 1995
EXTEND HIP SYSTEM
Wrightmedicaltechnologyinc
Orthopedic
77d
Cleared
Oct 25, 1995
ATH FULL PROFILE ACETABULAR CUP SYSTEM
Kinamed, Inc.
Orthopedic
48d
Cleared
Oct 23, 1995
VITALOCK SPIKED ACETABULAR SHELL
Howmedica Corp.
Orthopedic
77d
Cleared
Oct 20, 1995
TRILOGY ACETABULAR SHELL & LINERS 36MM
Zimmer, Inc.
Orthopedic
87d
Cleared
Aug 18, 1995
HOWMEDICA(R) ACETABULAR COMP PACK/MANUF METH CHANGE
Howmedica Corp.
Orthopedic
729d
Cleared
Aug 18, 1995
PACKAGING AND MANUFACTURING METHODS CHANGE/KNEE COMPONENTS
Howmedica Corp.
Orthopedic
610d
Cleared
Aug 18, 1995
DEPUY DURALOC 400 ACETABULAR CUP
Depuy, Inc.
Orthopedic
64d