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..

562
Total
562
Cleared
152d
Avg days
1984
Since
562 devices
289–312 of 562
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
Cleared Nov 19, 1999
EXACTECH ACUMATCH INTEGRATED HIP SYSTEM A-SERIES POROUS COATED ACETABULAR COMPONENT
K993082
Exactech, Inc.
Orthopedic · 65d
Cleared Nov 19, 1999
CROSSFIRE SYSTEM 12 ACETABULAR INSERTS
K993352
Howmedica Osteonics Corp.
Orthopedic · 45d
Cleared Oct 27, 1999
ZMR HIP SYSTEM-REVISION TAPER
K992667
Zimmer, Inc.
Orthopedic · 79d
Cleared Oct 22, 1999
REFLECTION CROSSLINKED UHMWPE ACETABULAR COMPONENTS
K991026
Smith & Nephew, Inc.
Orthopedic · 207d
Cleared Aug 12, 1999
ENCORE FULLY COATED HIP
K992109
Encore Orthopedics, Inc.
Orthopedic · 51d
Cleared Jul 12, 1999
TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHYLENE
K990135
Zimmer, Inc.
Orthopedic · 180d
Cleared Jul 12, 1999
SYNERGY POROUS SIZE 8 HIP STEM
K991485
Smith & Nephew, Inc.
Orthopedic · 75d
Cleared Jul 08, 1999
TITANIUM LOW PROFILE SCREWS
K991807
Biomet, Inc.
Orthopedic · 43d
Cleared Jul 01, 1999
HEDROCEL ACETABULAR CAGE SYSTEM
K983837
Implex Corp.
Orthopedic · 244d
Cleared Jun 25, 1999
MODIFICATION OF ENCORE LINEAR POROUS COATED HIP
K991325
Encore Orthopedics, Inc.
Orthopedic · 67d
Cleared Jun 01, 1999
PERFECTA RS LATERALIZED HIP STEM, BRIDGE HIP SYSTEM
K991123
Wrightmedicaltechnologyinc
Orthopedic · 60d
Cleared Feb 24, 1999
ECHELON HIP STEM
K983834
Smith & Nephew, Inc.
Orthopedic · 117d
Cleared Feb 18, 1999
LATERALIZED INTERGRAL POROUS PRIMARY FEMORAL COMPONENT
K984296
Biomet, Inc.
Orthopedic · 79d
Cleared Feb 12, 1999
130 MODIFIED INTEGRAL FEMORAL COMPONENT
K984408
Biomet, Inc.
Orthopedic · 65d
Cleared Feb 03, 1999
INTER-OP ACETABULAR SYSTEM - DURASUL ACETABULAR INSERT
K983509
Sulzer Orthopedics, Inc.
Orthopedic · 119d
Cleared Jan 28, 1999
DEPUY PROFILE FEMORAL HIP WITH POROCOAT
K984459
DePuy Orthopaedics, Inc.
Orthopedic · 44d
Cleared Dec 16, 1998
OSTEONICS SECUR-FIT AD GENERATION II ACETABULAR COMPONENT SYSTEM
K983502
Osteonics Corp.
Orthopedic · 71d
Cleared Dec 02, 1998
DEPUY DURALOC ACETABULAR CUP SYSTEM-ENDURON LINER
K983491
DePuy Orthopaedics, Inc.
Orthopedic · 58d
Cleared Nov 23, 1998
CUSTOM FLANGED ACETABULAR COMPONENT
K983035
Biomet, Inc.
Orthopedic · 84d
Cleared Nov 12, 1998
HARRIS/GALANTE POROUS (HGP) HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING
K980711
Zimmer, Inc.
Orthopedic · 261d
Cleared Oct 27, 1998
SUMMIT ACETABULAR SYSTEM
K983014
Johnson & Johnson Professionals, Inc.
Orthopedic · 60d
Cleared Aug 31, 1998
HOWMEDICA ASYMMETRIC STEM VITALOCK CLUSTER & SPIKED SHELLS, AND ACETABULAR SHELLS WITH MESH INGROWTH SURFACE WITH PERI-A
K982248
Howmedica, Inc.
Orthopedic · 66d