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..

564
Total
564
Cleared
152d
Avg days
1984
Since
564 devices
457–480 of 564
Cleared May 08, 1996
HEMISPHERE ACETABULAR CUP
K960660
Ortho Development Corp.
Orthopedic · 82d
Cleared May 02, 1996
22 MM COCR HEAD & POLYETHLENE LINER
K960180
Stelkast Company
Orthopedic · 107d
Cleared Mar 27, 1996
MODULAR ACETABULAR SHELL II
K955739
Intermedics Orthopedics
Orthopedic · 100d
Cleared Mar 27, 1996
DEPUY POROCOAT HPS II HIP PROSTHESIS W/ARTICUL-EZE TAPER
K960172
Depuy, Inc.
Orthopedic · 71d
Cleared Mar 22, 1996
HOWMEDICA ASYMMETRIC STEM FEMORAL COMPONENT
K955871
Howmedica Corp.
Orthopedic · 87d
Cleared Feb 26, 1996
ARTHOPOR I & II ACETABULAR CUP/ARTHOPOR II OBLONG ACETABULAR CUP
K955511
Joint Medical Products Corp.
Orthopedic · 84d
Cleared Feb 09, 1996
NEXFLEX FEMORAL STEM, STANDARD DESIGN
K955170
Nexmed, Inc.
Orthopedic · 88d
Cleared Feb 01, 1996
DEPUY VISION AML HIP PROTHESIS
K953694
Depuy, Inc.
Orthopedic · 177d
Cleared Feb 01, 1996
DEPUY VISION SOLUTION HIP PROSTHESIS
K953703
Depuy, Inc.
Orthopedic · 177d
Cleared Jan 31, 1996
RIM FLARE ACETABULAR COMPONENT
K955033
Intermedics Orthopedics
Orthopedic · 90d
Cleared Jan 30, 1996
MICRO-SEAL ACETABULAR SYSTEM
K955271
Whiteside Instruments
Orthopedic · 76d
Cleared Jan 22, 1996
BETA HIP PROSTHESIS
K953337
Zimmer, Inc.
Orthopedic · 189d
Cleared Jan 22, 1996
S-ROM FEMORAL HIP STEM - SIZE 14 X 8
K954935
Joint Medical Products Corp.
Orthopedic · 87d
Cleared Jan 17, 1996
TRILOGY ACETABULAR COMPONENT 7MM OFFSET
K954698
Zimmer, Inc.
Orthopedic · 97d
Cleared Jan 17, 1996
DEPUY ADVANTAGE HIP FEMORAL PROSTHESIS WITH POROCOAT
K954811
Depuy, Inc.
Orthopedic · 90d
Cleared Dec 11, 1995
A-B ACETABULAR COMPONENT
K954417
Biomet, Inc.
Orthopedic · 81d
Cleared Dec 04, 1995
PROFORM POROUS BEADED FEMORAL STEM
K954466
Stelkast Company
Orthopedic · 70d
Cleared Nov 30, 1995
EXTEND HIP SYSTEM
K954288
Wrightmedicaltechnologyinc
Orthopedic · 77d
Cleared Oct 25, 1995
ATH FULL PROFILE ACETABULAR CUP SYSTEM
K954213
Kinamed, Inc.
Orthopedic · 48d
Cleared Oct 23, 1995
VITALOCK SPIKED ACETABULAR SHELL
K953664
Howmedica Corp.
Orthopedic · 77d
Cleared Oct 20, 1995
TRILOGY ACETABULAR SHELL & LINERS 36MM
K953490
Zimmer, Inc.
Orthopedic · 87d
Cleared Aug 18, 1995
HOWMEDICA(R) ACETABULAR COMP PACK/MANUF METH CHANGE
K934060
Howmedica Corp.
Orthopedic · 729d
Cleared Aug 18, 1995
PACKAGING AND MANUFACTURING METHODS CHANGE/KNEE COMPONENTS
K936292
Howmedica Corp.
Orthopedic · 610d
Cleared Aug 18, 1995
DEPUY DURALOC 400 ACETABULAR CUP
K952740
Depuy, Inc.
Orthopedic · 64d