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 DePuy Orthopaedics, Inc..

561
Total
561
Cleared
152d
Avg days
1984
Since
561 devices
193–216 of 561
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 05, 2001
TRIOLOGY ACETABULAR SYSTEM 46MM LARGE HEAD LINERS, MODEL 6310
K003478
Zimmer, Inc.
Orthopedic · 88d
Cleared Dec 15, 2000
REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS
K002747
Smith & Nephew, Inc.
Orthopedic · 101d
Cleared Dec 11, 2000
TRILOGY ACETABULAR SYSTEM LARGE HEAD LINER, MODEL 6353
K002960
Zimmer, Inc.
Orthopedic · 80d
Cleared Nov 30, 2000
MALLOY/HEAD LATERALIZED PRESS-FIT FEMORAL
K003429
Biomet, Inc.
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
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 12, 2000
PINNACLE ACETABULAR SYSTEM
K001534
DePuy Orthopaedics, Inc.
Orthopedic · 26d
Cleared May 23, 2000
REACH FEMORAL COMPONENT
K000760
Biomet, Inc.
Orthopedic · 76d
Cleared Apr 11, 2000
MALLORY/HEAD CALCAR REPLACEMENT WITH INTERLOCKING SLOTS BI-METRIC POROUS COLLARED STEM WITH INTERLOCKING SLOTS
K990830
Biomet, Inc.
Orthopedic · 396d
Cleared Mar 23, 2000
PINNACLE ACETABULAR SYSTEM
K000306
DePuy Orthopaedics, Inc.
Orthopedic · 51d
Cleared Mar 15, 2000
MALLORY/HEAD LATERALIZED PRESS-FIT FEMORAL
K000538
Biomet, Inc.
Orthopedic · 27d
Cleared Mar 10, 2000
ZMR HIP SYSTEM-POROUS REVISION
K994286
Zimmer, Inc.
Orthopedic · 81d
Cleared Feb 25, 2000
MALLORY-HEAD MODULAR CALCAR TOTAL HIP SYSTEM
K000335
Biomet, Inc.
Orthopedic · 22d
Cleared Feb 16, 2000
IMPACT MODULAR TOTAL HIP SYSTEM
K000334
Biomet, Inc.
Orthopedic · 13d
Cleared Feb 04, 2000
POROCOAT PRODIGY HIP PROSTHESIS
K000207
DePuy Orthopaedics, Inc.
Orthopedic · 11d
Cleared Feb 03, 2000
MARATHON CROSS-LINKED POLYETHYLENE ACETABULAR CUP LINERS
K994415
DePuy Orthopaedics, Inc.
Orthopedic · 36d
Cleared Dec 22, 1999
MODULAR REACH HIP
K994038
Biomet, Inc.
Orthopedic · 23d
Cleared Dec 20, 1999
DURATION IV STERILIZATION PROCESS (ACETABULAR INSERTS)
K990849
Howmedica Osteonics Corp.
Orthopedic · 280d