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 Smith & Nephew, Inc..

561
Total
561
Cleared
152d
Avg days
1984
Since
561 devices
169–192 of 561
Cleared Jun 24, 2003
ZMR HIP SYSTEM-XL, MODELS 9921, 9922 AND 9923
K031572
Zimmer, Inc.
Orthopedic · 35d
Cleared Jun 12, 2003
HA PMI FLANGED ACETABULAR COMPONENT
K030861
Biomet, Inc.
Orthopedic · 86d
Cleared Jun 11, 2003
PINNACLE DUOFIX HA ACETABULAR CUP PROSTHESIS
K031495
DePuy Orthopaedics, Inc.
Orthopedic · 29d
Cleared May 01, 2003
MAYO CONSERVATIVE HIP PROSTHESIS, MODEL 8026 SERIES
K030733
Zimmer, Inc.
Orthopedic · 52d
Cleared Apr 24, 2003
MODIFICATION TO DEPUY SOLUTION SYSTEM HIP PROSTHESIS
K030979
DePuy Orthopaedics, Inc.
Orthopedic · 27d
Cleared Mar 20, 2003
X-SERIES INTEGRAL LATERALIZED HIP COMPONENTS
K030501
Biomet, Inc.
Orthopedic · 29d
Cleared Feb 05, 2003
VERSYS BEADED FULLCOAT BOWED REVISION HIP PROSTHESIS
K030079
Zimmer, Inc.
Orthopedic · 27d
Cleared Nov 08, 2002
HA X-SERIES BI-METRIC HIP FEMORAL COMPONENTS
K023409
Biomet, Inc.
Orthopedic · 29d
Cleared Oct 02, 2002
SMITH & NEPHEW HIP SYSTEM
K022902
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Sep 05, 2002
ZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEM
K021891
Zimmer, Inc.
Orthopedic · 90d
Cleared Aug 28, 2002
REFLECTION MODIFIED ACETABULAR SHELLS
K022556
Smith & Nephew, Inc.
Orthopedic · 26d
Cleared Jul 30, 2002
EPOCH HIP PROSTHESIS, MODEL 4075 SERIES
K014070
Zimmer, Inc.
Orthopedic · 232d
Cleared Jul 02, 2002
STEM HIP REPLACEMENT SYSTEM, MODEL PHA002XX
K021346
Wrightmedicaltechnologyinc
Orthopedic · 64d
Cleared Jul 02, 2002
TRIDENT CROSSFIRE POLYUETHYLENE LINERS
K021911
Howmedica Osteonics Corp.
Orthopedic · 21d
Cleared Mar 22, 2002
X-SERIES BI-METRIC HIP FEMORAL COMPONENTS
K020580
Biomet, Inc.
Orthopedic · 29d
Cleared Mar 15, 2002
VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPONENTS IN THE REFLECTION ACTABULAR SYSTEM (ACETABULAR LINE
K012787
Smith & Nephew, Inc.
Orthopedic · 207d
Cleared Mar 04, 2002
TRIDENT ELEVATED RIM LINER
K020497
Howmedica Osteonics Corp.
Orthopedic · 18d
Cleared Dec 20, 2001
TRIDENT POROUS TITANIUM ACETABULAR COMPONENT WITH PERI-APATITE COATING
K013475
Howmedica Osteonics Corp.
Orthopedic · 62d
Cleared Dec 05, 2001
MODIFICATION TO REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS
K013658
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Oct 19, 2001
AML HIP PROSTHESIS
K012364
DePuy Orthopaedics, Inc.
Orthopedic · 85d
Cleared Jul 31, 2001
SUMMIT DUOFIX HIP PROSTHESIS
K011489
DePuy Orthopaedics, Inc.
Orthopedic · 77d
Cleared Apr 18, 2001
TRIDENT POROUS TITANIUM ACETABULAR COMPONENT
K010170
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Apr 06, 2001
DURALOC ACETABULAR CUP SYSTEM, 36MM MARATHON +4 POLYETHYLENE LINER
K010171
DePuy Orthopaedics, Inc.
Orthopedic · 78d
Cleared Mar 09, 2001
MODIFICATION TO TITANIUM TRI-LOCK HIPS STEM
K010367
DePuy Orthopaedics, Inc.
Orthopedic · 30d