LPH · Class II · 21 CFR 888.3358

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
385–408 of 564
Cleared Jun 25, 1999
MODIFICATION OF ENCORE LINEAR POROUS COATED HIP
K991325
Encore Orthopedics, Inc.
Orthopedic · 67d
Cleared Jun 01, 1999
PERFECTA RS LATERALIZED HIP STEM, BRIDGE HIP SYSTEM
K991123
Wrightmedicaltechnologyinc
Orthopedic · 60d
Cleared Apr 30, 1999
B2C, ESPACE REVISION CUP SYSTEM
K990523
Turnkey Intergration USA, Inc.
Orthopedic · 70d
Cleared Mar 15, 1999
TIGRAN HIP PROSTHESIS
K984492
Ponmed , Ltd.
Orthopedic · 88d
Cleared Feb 24, 1999
ECHELON HIP STEM
K983834
Smith & Nephew, Inc.
Orthopedic · 117d
Cleared Feb 24, 1999
J-SERIES OMEGA TOTAL HIP SYSTEM
K990003
Osteoimplant Technology, Inc.
Orthopedic · 51d
Cleared Feb 18, 1999
LATERALIZED INTERGRAL POROUS PRIMARY FEMORAL COMPONENT
K984296
Biomet, Inc.
Orthopedic · 79d
Cleared Feb 12, 1999
130 MODIFIED INTEGRAL FEMORAL COMPONENT
K984408
Biomet, Inc.
Orthopedic · 65d
Cleared Feb 03, 1999
INTER-OP ACETABULAR SYSTEM - DURASUL ACETABULAR INSERT
K983509
Sulzer Orthopedics, Inc.
Orthopedic · 119d
Cleared Jan 28, 1999
DEPUY PROFILE FEMORAL HIP WITH POROCOAT
K984459
DePuy Orthopaedics, Inc.
Orthopedic · 44d
Cleared Dec 16, 1998
OSTEONICS SECUR-FIT AD GENERATION II ACETABULAR COMPONENT SYSTEM
K983502
Osteonics Corp.
Orthopedic · 71d
Cleared Dec 02, 1998
DEPUY DURALOC ACETABULAR CUP SYSTEM-ENDURON LINER
K983491
DePuy Orthopaedics, Inc.
Orthopedic · 58d
Cleared Nov 23, 1998
CUSTOM FLANGED ACETABULAR COMPONENT
K983035
Biomet, Inc.
Orthopedic · 84d
Cleared Nov 12, 1998
HARRIS/GALANTE POROUS (HGP) HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING
K980711
Zimmer, Inc.
Orthopedic · 261d
Cleared Oct 27, 1998
SUMMIT ACETABULAR SYSTEM
K983014
Johnson & Johnson Professionals, Inc.
Orthopedic · 60d
Cleared Aug 31, 1998
HOWMEDICA ASYMMETRIC STEM VITALOCK CLUSTER & SPIKED SHELLS, AND ACETABULAR SHELLS WITH MESH INGROWTH SURFACE WITH PERI-A
K982248
Howmedica, Inc.
Orthopedic · 66d
Cleared Aug 24, 1998
REACH HIP COMPONENT
K982367
Biomet, Inc.
Orthopedic · 48d
Cleared May 22, 1998
APR -T REVISION HIP STEM
K981211
Sulzer Orthopedics, Inc.
Orthopedic · 50d
Cleared May 20, 1998
OMEGA HA COATED TOTAL HIP SYSTEM
K980981
Osteoimplant Technology, Inc.
Orthopedic · 64d
Cleared Apr 03, 1998
ACTIVELOCK MODULAR FEMORAL HIP SYSTEM
K980020
Metagen, LLC
Orthopedic · 88d
Cleared Mar 18, 1998
DEPUY TRI-LOCK HIP STEM
K974740
Depuy, Inc.
Orthopedic · 89d
Cleared Feb 27, 1998
LSF HA COATED TRIAD TOTAL HIP SYSTEM
K974506
Osteoimplant Technology, Inc.
Orthopedic · 88d
Cleared Feb 11, 1998
MERIDIAN ST FEMORAL STEM AND VITALOCK SOLID BACK SHELL W/ PERI-APATITE COATING
K971206
Howmedica Corp.
Orthopedic · 336d
Cleared Feb 06, 1998
UNI-ROM TOTAL HIP SYSTEM FEMORAL STEM
K974331
Johnson & Johnson Professionals, Inc.
Orthopedic · 80d