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..

564
Total
564
Cleared
152d
Avg days
1984
Since
564 devices
313–336 of 564
Cleared Aug 28, 2002
REFLECTION MODIFIED ACETABULAR SHELLS
K022556
Smith & Nephew, Inc.
Orthopedic · 26d
Cleared Aug 16, 2002
HA MODULAR REACH PROXIMAL POROUS AND HA MODULAR REACH COLLARED PROXIMAL POROUS FEMORAL STEMS
K022463
Biomet Orthopedics, Inc.
Orthopedic · 21d
Cleared Jul 30, 2002
EPOCH HIP PROSTHESIS, MODEL 4075 SERIES
K014070
Zimmer, Inc.
Orthopedic · 232d
Cleared Jul 12, 2002
THE TRABECULAR METAL MONOBLOCK CUP, MODELS 00-7259-0XX-28 (ZIMMER CAT. #) AND 02-293-28XX1 (IMPLEX PART #)
K021970
Implex Corp.
Orthopedic · 25d
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 Feb 11, 2002
KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UP
K020170
Encore Orthopedics, Inc.
Orthopedic · 25d
Cleared Jan 17, 2002
CEMENTED CALCAR HIP SYSTEM
K013490
Encore Orthopedics, Inc.
Orthopedic · 87d
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 Nov 14, 2001
CONVERGE ACETABULAR SYSTEM
K012739
Sulzer Orthopedics, Inc.
Orthopedic · 90d
Cleared Oct 19, 2001
AML HIP PROSTHESIS
K012364
DePuy Orthopaedics, Inc.
Orthopedic · 85d
Cleared Aug 30, 2001
THE TRABECULAR METAL TECHNOLOGY ACETABULAR AUGMENT SYSTEM, MODELS 4893-XX-YY (ZIMMER), 02-212-05XX1 ( IMPLEX)
K012507
Implex Corp.
Orthopedic · 24d
Cleared Jul 31, 2001
SUMMIT DUOFIX HIP PROSTHESIS
K011489
DePuy Orthopaedics, Inc.
Orthopedic · 77d
Cleared Apr 24, 2001
ACUMATCH M-SERIES EXTRA-SMALL METAPHYSEAL SEGMENTS
K011081
Exactech, Inc.
Orthopedic · 14d
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
Cleared Mar 01, 2001
TI-REPLICA HIP STEM
K003875
DePuy Orthopaedics, Inc.
Orthopedic · 76d
Cleared Feb 15, 2001
PERFECTA AND EXTEND
K004032
Wrightmedicaltechnologyinc
Orthopedic · 49d
Cleared Feb 09, 2001
AML HIP PROSTHESIS
K003800
DePuy Orthopaedics, Inc.
Orthopedic · 63d