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..
561
Total
561
Cleared
152d
Avg days
1984
Since
561 devices
Cleared
Aug 14, 1997
DEPUY PROXIMAL FEMORAL REPLACEMENT PROSTHESIS
Depuy, Inc.
Orthopedic
204d
Cleared
Jul 30, 1997
OSTEOLOCK ACETABULAR SHELL SYSTEM
Howmedica Corp.
Orthopedic
71d
Cleared
Jul 09, 1997
INTERSEAL ACETABULAR SCREW HOLE PLUG
Wrightmedicaltechnologyinc
Orthopedic
82d
Cleared
Jun 19, 1997
TCP-COATED POROCOAT AML FEMORAL HIP PROSTHESIS
Depuy, Inc.
Orthopedic
211d
Cleared
Apr 30, 1997
PEGGED ACETABULAR COMPONENT
Biomet, Inc.
Orthopedic
79d
Cleared
Mar 13, 1997
HOWMEDICA MODULAR REPLACEMENT SYSTEM-PROXIMAL FEMUR
Howmedica Corp.
Orthopedic
79d
Cleared
Feb 13, 1997
VERSYS HIP SYSTEM--FIBER METAL TAPER HIP PROSTHESIS
Zimmer, Inc.
Orthopedic
78d
Cleared
Nov 12, 1996
APEX HOLE ELIMINATOR PS
Depuy, Inc.
Orthopedic
82d
Cleared
Oct 01, 1996
DEPUY GRADED POROSITY AML HIP (1371-03/06-500/1371-43/46-500)
Depuy, Inc.
Orthopedic
64d
Cleared
Sep 17, 1996
DEPUY DURALOC CEMENTLESS ACETABULAR CUP SYSTEM
Depuy, Inc.
Orthopedic
175d
Cleared
Aug 13, 1996
S-ROM FEMORAL HIP STEM(SIZES 12 X 06 X 115 AND 12 X 07 X 115)
Johnson & Johnson Professionals, Inc.
Orthopedic
85d
Cleared
Jun 21, 1996
FENNING FEMORAL COMPONENT
Biomet, Inc.
Orthopedic
151d
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 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 22, 1996
BETA HIP PROSTHESIS
Zimmer, Inc.
Orthopedic
189d
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
Nov 30, 1995
EXTEND HIP SYSTEM
Wrightmedicaltechnologyinc
Orthopedic
77d
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