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..
562
Total
562
Cleared
152d
Avg days
1984
Since
562 devices
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 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
Dec 04, 1995
PROFORM POROUS BEADED FEMORAL STEM
Stelkast Company
Orthopedic
70d
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
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
Cleared
Aug 14, 1995
OSTEONICS PS HEMI-HIP STEM SERIES
Osteonics Corp.
Orthopedic
734d
Cleared
Jul 21, 1995
VITALOCK SOLID BACKED ACETABULAR SHELL
Howmedica Corp.
Orthopedic
60d
Cleared
Jul 06, 1995
F-230 POROUS FEMORAL HIP STEM (CEMENTLESS)
Implex Corp.
Orthopedic
458d
Cleared
Jun 16, 1995
SYSTEM 12 P1 26MM ACETABULAR INSERT
Howmedica Corp.
Orthopedic
98d
Cleared
Jun 16, 1995
HOWMEDICA VITALOCK 22MM ACERTABULAR SHELL AND SYSTEM 12 INSERTS
Howmedica Corp.
Orthopedic
98d
Cleared
Jun 07, 1995
ORTHOMET HMC FEMORAL STEM COMPONENT
Orthomet, Inc.
Orthopedic
426d
Cleared
Jun 07, 1995
OSTEONICS OMNIFIT AD HIP STEM SERIES
Osteonics Corp.
Orthopedic
474d
Cleared
May 17, 1995
PRECISION OSTEOLOCK FEMORAL COMPONENT
Howmedica Corp.
Orthopedic
240d
Cleared
May 11, 1995
DEPUY DURALOC 100C ACETABULAR CUP
Depuy, Inc.
Orthopedic
30d
Cleared
Apr 27, 1995
10.5MM REPLICA HIP STEM
Depuy, Inc.
Orthopedic
50d