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 Smith & Nephew, Inc..
564
Total
564
Cleared
152d
Avg days
1984
Since
564 devices
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
Cleared
Apr 18, 1995
PROFORM POROUS ACETABULAR ASSEMBLY
Stelkast Company
Orthopedic
54d
Cleared
Apr 18, 1995
DEPUY DURALOC CEMENTLESS ACETABULAR CUP SYSTEM
Depuy, Inc.
Orthopedic
27d
Cleared
Apr 14, 1995
ZTT I AND II ACETABULAR CUP OF THE S-ROM TOTAL HIP SYSTEM
Joint Medical Products Corp.
Orthopedic
42d
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
Oct 14, 1994
ORTHOMET ACETABULAR CUP SYSTEM
Orthomet, Inc.
Orthopedic
577d
Cleared
Oct 04, 1994
OSTEONICS SECURE-FIT AD ACETABULAR COMPONENT SYSTEM
Osteonics Corp.
Orthopedic
99d
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
Jul 29, 1994
OSTEONICS SCREWLESS ACETABULAR COMPONENTS
Osteonics Corp.
Orthopedic
232d
Cleared
Jun 06, 1994
PROVIDENT HIP SYSTEM
Stelkast Company
Orthopedic
203d
Cleared
Jun 03, 1994
COATED ZT PROXIMAL SLEEVE
Joint Medical Products Corp.
Orthopedic
266d
Cleared
May 16, 1994
HOWMEDICA ACETABULAR SHELL W/SCREW HOLES
Howmedica Corp.
Orthopedic
326d
Cleared
May 12, 1994
IMPLEX A-230 POROUS ACETABULAR CUP SYST. CEMENTED
Implex Corp.
Orthopedic
331d