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..

565
Total
565
Cleared
152d
Avg days
1984
Since
565 devices
337–360 of 565
Cleared Apr 15, 2002
ORTHOPAEDIC INNOVATIONS RENEWAL ACETABULAR CUP SYSTEM
K020145
Orthopaedic Innovations, Inc.
Orthopedic · 89d
Cleared Apr 15, 2002
CONSENSUS ACETABLAR SHELL, TI COATED
K020153
Hayes Medical, Inc.
Orthopedic · 89d
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
Cleared Feb 09, 2001
MODIFICATION TO EXACTECH ACUMATCH INTEGRATED HIP SYSTEM, M-SERIES HIGH OFF-SET NECK SEGMENT, M-SERIES LOW OFF-SET NECK S
K010120
Exactech, Inc.
Orthopedic · 24d
Cleared Feb 09, 2001
LATERAL OFFSET PROTRACT PRESS FIT HIP STEM
K010282
Stelkast Company
Orthopedic · 10d
Cleared Feb 08, 2001
PROTRACT PRESS FIT HIP STEM-HA COATED
K010241
Stelkast Company
Orthopedic · 14d
Cleared Feb 05, 2001
TRIOLOGY ACETABULAR SYSTEM 46MM LARGE HEAD LINERS, MODEL 6310
K003478
Zimmer, Inc.
Orthopedic · 88d