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
Cleared
Jan 10, 2001
TRIAD II MODULAR TOTAL HIP SYSTEM
Osteoimplant Technology, Inc.
Orthopedic
90d
Cleared
Jan 10, 2001
U2 HIP STEM, TI POROUS COATED
United Orthopedic Corp.
Orthopedic
85d
Cleared
Dec 15, 2000
REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS
Smith & Nephew, Inc.
Orthopedic
101d
Cleared
Dec 15, 2000
PROTRACT PRESS FIT HIP STEM
Stelkast Company
Orthopedic
39d
Cleared
Dec 11, 2000
TRILOGY ACETABULAR SYSTEM LARGE HEAD LINER, MODEL 6353
Zimmer, Inc.
Orthopedic
80d
Cleared
Dec 04, 2000
U1 HIP SYSTEM
United Orthopedic Corp.
Orthopedic
368d
Cleared
Nov 30, 2000
MALLOY/HEAD LATERALIZED PRESS-FIT FEMORAL
Biomet, Inc.
Orthopedic
27d
Cleared
Nov 07, 2000
IMPLEX CONTINUUM HIP SYSTEM ACETABULAR COMPONENTS - MODEL XX-YYY-ZZZZ
Implex Corp.
Orthopedic
27d
Cleared
Aug 31, 2000
LINEAGE ACETABULAR SYSTEM
Wrightmedicaltechnologyinc
Orthopedic
45d
Cleared
Aug 25, 2000
TITAN POROCOAT HIP PROSTHESIS
DePuy Orthopaedics, Inc.
Orthopedic
57d
Cleared
Aug 04, 2000
APEX MODULAR HIP STEM
Apex Surgical, LLC
Orthopedic
147d
Cleared
Jul 26, 2000
TRI-LOCK HIP STEM
DePuy Orthopaedics, Inc.
Orthopedic
27d
Cleared
Jul 07, 2000
SULZER ORTHOPEDICS INC. NATURAL-HIP SYSTEM LD STEM
Sulzer Orthopedics, Inc.
Orthopedic
72d
Cleared
Jul 07, 2000
POROCOAT PRODIGY HIP PROSTHESIS
DePuy Orthopaedics, Inc.
Orthopedic
24d
Cleared
Jun 23, 2000
TRIFLANGE ACETABULAR CUP SYSTEM
DePuy Orthopaedics, Inc.
Orthopedic
63d
Cleared
Jun 15, 2000
THE IMPLEX HEDROCEL MODULAR ELLIPTICAL ACETABULAR CUP
Implex Corp.
Orthopedic
76d
Cleared
Jun 14, 2000
MALLORY HEAD MODULAR CALCAR
Biomet Orthopedics, Inc.
Orthopedic
14d
Cleared
Jun 12, 2000
PINNACLE ACETABULAR SYSTEM
DePuy Orthopaedics, Inc.
Orthopedic
26d
Cleared
May 23, 2000
REACH FEMORAL COMPONENT
Biomet, Inc.
Orthopedic
76d
Cleared
May 10, 2000
KEYSTONE HIP
Encore Orthopedics, Inc.
Orthopedic
84d
Cleared
Apr 11, 2000
MALLORY/HEAD CALCAR REPLACEMENT WITH INTERLOCKING SLOTS BI-METRIC POROUS COLLARED STEM WITH INTERLOCKING SLOTS
Biomet, Inc.
Orthopedic
396d
Cleared
Apr 10, 2000
HEMISPHERE MODULAR CUP SYSTEM
Ortho Development Corp.
Orthopedic
68d
Cleared
Apr 06, 2000
BICON-PLUS ACETABULAR COMPONENTS
Plus Orthopedics
Orthopedic
286d
Cleared
Apr 06, 2000
ESKA MODULAR HIP SYSTEM
Specs USA, Inc.
Orthopedic
210d