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
337–360 of 564
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
Cleared Jan 10, 2001
TRIAD II MODULAR TOTAL HIP SYSTEM
K003199
Osteoimplant Technology, Inc.
Orthopedic · 90d
Cleared Jan 10, 2001
U2 HIP STEM, TI POROUS COATED
K003237
United Orthopedic Corp.
Orthopedic · 85d
Cleared Dec 15, 2000
REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS
K002747
Smith & Nephew, Inc.
Orthopedic · 101d
Cleared Dec 15, 2000
PROTRACT PRESS FIT HIP STEM
K003447
Stelkast Company
Orthopedic · 39d
Cleared Dec 11, 2000
TRILOGY ACETABULAR SYSTEM LARGE HEAD LINER, MODEL 6353
K002960
Zimmer, Inc.
Orthopedic · 80d
Cleared Dec 04, 2000
U1 HIP SYSTEM
K994078
United Orthopedic Corp.
Orthopedic · 368d
Cleared Nov 30, 2000
MALLOY/HEAD LATERALIZED PRESS-FIT FEMORAL
K003429
Biomet, Inc.
Orthopedic · 27d
Cleared Nov 07, 2000
IMPLEX CONTINUUM HIP SYSTEM ACETABULAR COMPONENTS - MODEL XX-YYY-ZZZZ
K003181
Implex Corp.
Orthopedic · 27d
Cleared Aug 31, 2000
LINEAGE ACETABULAR SYSTEM
K002149
Wrightmedicaltechnologyinc
Orthopedic · 45d
Cleared Aug 25, 2000
TITAN POROCOAT HIP PROSTHESIS
K001991
DePuy Orthopaedics, Inc.
Orthopedic · 57d
Cleared Jul 26, 2000
TRI-LOCK HIP STEM
K001982
DePuy Orthopaedics, Inc.
Orthopedic · 27d
Cleared Jul 07, 2000
SULZER ORTHOPEDICS INC. NATURAL-HIP SYSTEM LD STEM
K001320
Sulzer Orthopedics, Inc.
Orthopedic · 72d
Cleared Jul 07, 2000
POROCOAT PRODIGY HIP PROSTHESIS
K001778
DePuy Orthopaedics, Inc.
Orthopedic · 24d
Cleared Jun 23, 2000
TRIFLANGE ACETABULAR CUP SYSTEM
K001277
DePuy Orthopaedics, Inc.
Orthopedic · 63d
Cleared Jun 15, 2000
THE IMPLEX HEDROCEL MODULAR ELLIPTICAL ACETABULAR CUP
K001039
Implex Corp.
Orthopedic · 76d
Cleared Jun 14, 2000
MALLORY HEAD MODULAR CALCAR
K001660
Biomet Orthopedics, Inc.
Orthopedic · 14d
Cleared Jun 12, 2000
PINNACLE ACETABULAR SYSTEM
K001534
DePuy Orthopaedics, Inc.
Orthopedic · 26d
Cleared May 23, 2000
REACH FEMORAL COMPONENT
K000760
Biomet, Inc.
Orthopedic · 76d
Cleared May 10, 2000
KEYSTONE HIP
K000521
Encore Orthopedics, Inc.
Orthopedic · 84d
Cleared Apr 11, 2000
MALLORY/HEAD CALCAR REPLACEMENT WITH INTERLOCKING SLOTS BI-METRIC POROUS COLLARED STEM WITH INTERLOCKING SLOTS
K990830
Biomet, Inc.
Orthopedic · 396d