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..

561
Total
561
Cleared
152d
Avg days
1984
Since
561 devices
217–240 of 561
Cleared Nov 19, 1999
CROSSFIRE SYSTEM 12 ACETABULAR INSERTS
K993352
Howmedica Osteonics Corp.
Orthopedic · 45d
Cleared Oct 27, 1999
ZMR HIP SYSTEM-REVISION TAPER
K992667
Zimmer, Inc.
Orthopedic · 79d
Cleared Oct 22, 1999
REFLECTION CROSSLINKED UHMWPE ACETABULAR COMPONENTS
K991026
Smith & Nephew, Inc.
Orthopedic · 207d
Cleared Jul 12, 1999
TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHYLENE
K990135
Zimmer, Inc.
Orthopedic · 180d
Cleared Jul 12, 1999
SYNERGY POROUS SIZE 8 HIP STEM
K991485
Smith & Nephew, Inc.
Orthopedic · 75d
Cleared Jul 08, 1999
TITANIUM LOW PROFILE SCREWS
K991807
Biomet, Inc.
Orthopedic · 43d
Cleared Jun 01, 1999
PERFECTA RS LATERALIZED HIP STEM, BRIDGE HIP SYSTEM
K991123
Wrightmedicaltechnologyinc
Orthopedic · 60d
Cleared Feb 24, 1999
ECHELON HIP STEM
K983834
Smith & Nephew, Inc.
Orthopedic · 117d
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 Jan 28, 1999
DEPUY PROFILE FEMORAL HIP WITH POROCOAT
K984459
DePuy Orthopaedics, Inc.
Orthopedic · 44d
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 24, 1998
REACH HIP COMPONENT
K982367
Biomet, Inc.
Orthopedic · 48d
Cleared Mar 18, 1998
DEPUY TRI-LOCK HIP STEM
K974740
Depuy, Inc.
Orthopedic · 89d
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
Cleared Dec 24, 1997
VERSYS HIP SYSTEM BEADED HIP PROSTHESIS
K973714
Zimmer, Inc.
Orthopedic · 86d
Cleared Dec 04, 1997
REACH FEMORAL HIP COMPONENT
K971824
Biomet, Inc.
Orthopedic · 202d
Cleared Nov 21, 1997
ACETABULAR SHELLS WITH MESH INGROWTH SURFACE
K973163
Howmedica Corp.
Orthopedic · 88d
Cleared Nov 12, 1997
DEPUY DURALOC ACETABULAR CUP SYSTEM
K972596
Depuy, Inc.
Orthopedic · 124d
Cleared Oct 16, 1997
INFINTY DISTAL FEMORAL COMPONENT
K973530
Wrightmedicaltechnologyinc
Orthopedic · 28d