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 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
Jul 21, 1995
VITALOCK SOLID BACKED ACETABULAR SHELL
Howmedica Corp.
Orthopedic
60d
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
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
Cleared
Apr 18, 1995
DEPUY DURALOC CEMENTLESS ACETABULAR CUP SYSTEM
Depuy, Inc.
Orthopedic
27d
Cleared
Mar 07, 1995
BIAS(TM) FIBER METAL TOTAL HIP STEM (TFB)
Zimmer, Inc.
Orthopedic
538d
Cleared
Dec 21, 1994
APOGEE HIP STEM WITH POROCOAT
Depuy, Inc.
Orthopedic
470d
Cleared
Sep 28, 1994
PRECISION OSTELOCK SP FEMORAL COMPONENT
Howmedica Corp.
Orthopedic
202d
Cleared
Sep 28, 1994
INFINITY REVISION HIP STEM
Wrightmedicaltechnologyinc
Orthopedic
148d
Cleared
May 16, 1994
HOWMEDICA ACETABULAR SHELL W/SCREW HOLES
Howmedica Corp.
Orthopedic
326d
Cleared
Apr 29, 1994
TRILOGY ACETABULAR SYSTEM
Zimmer, Inc.
Orthopedic
206d
Cleared
Apr 13, 1994
POROCOAT POROUS COATING/AML PROXIMALLY-COATED STEM
Depuy, Inc.
Orthopedic
252d
Cleared
Mar 21, 1994
POROCOAT POROUS COATING
Depuy, Inc.
Orthopedic
353d
Cleared
Mar 03, 1994
ACETABULAR SHELL
Howmedica Corp.
Orthopedic
92d
Cleared
Feb 22, 1994
HG MULTILOCK HIP PROSTHESIS W/ TI-NIDIUM
Zimmer, Inc.
Orthopedic
705d
Cleared
Feb 22, 1994
BIAS TOTAL HIP SYSTEM ACETABULAR COMPONENT
Zimmer, Inc.
Orthopedic
692d
Cleared
Feb 22, 1994
ZIMMER ANATOMIC HIP SYSTEM
Zimmer, Inc.
Orthopedic
659d
Cleared
Feb 22, 1994
PCA(R) E SERIES HIP SYSTEM (CEMENTLESS USE)
Howmedica Corp.
Orthopedic
496d
Cleared
Feb 16, 1994
RANAWAT/BURSTEIN TOTAL HIP SYSTEM
Biomet, Inc.
Orthopedic
701d
Cleared
Feb 16, 1994
TAPERLOC FEMORAL STEM AND UNIVERSAL ACETABULAR COM
Biomet, Inc.
Orthopedic
700d