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
241–264 of 561
Cleared Aug 14, 1997
DEPUY PROXIMAL FEMORAL REPLACEMENT PROSTHESIS
K970241
Depuy, Inc.
Orthopedic · 204d
Cleared Jul 30, 1997
OSTEOLOCK ACETABULAR SHELL SYSTEM
K971854
Howmedica Corp.
Orthopedic · 71d
Cleared Jul 09, 1997
INTERSEAL ACETABULAR SCREW HOLE PLUG
K971429
Wrightmedicaltechnologyinc
Orthopedic · 82d
Cleared Jun 19, 1997
TCP-COATED POROCOAT AML FEMORAL HIP PROSTHESIS
K964650
Depuy, Inc.
Orthopedic · 211d
Cleared Apr 30, 1997
PEGGED ACETABULAR COMPONENT
K970501
Biomet, Inc.
Orthopedic · 79d
Cleared Mar 13, 1997
HOWMEDICA MODULAR REPLACEMENT SYSTEM-PROXIMAL FEMUR
K965164
Howmedica Corp.
Orthopedic · 79d
Cleared Feb 13, 1997
VERSYS HIP SYSTEM--FIBER METAL TAPER HIP PROSTHESIS
K964769
Zimmer, Inc.
Orthopedic · 78d
Cleared Nov 12, 1996
APEX HOLE ELIMINATOR PS
K963309
Depuy, Inc.
Orthopedic · 82d
Cleared Oct 01, 1996
DEPUY GRADED POROSITY AML HIP (1371-03/06-500/1371-43/46-500)
K962923
Depuy, Inc.
Orthopedic · 64d
Cleared Sep 17, 1996
DEPUY DURALOC CEMENTLESS ACETABULAR CUP SYSTEM
K961186
Depuy, Inc.
Orthopedic · 175d
Cleared Aug 13, 1996
S-ROM FEMORAL HIP STEM(SIZES 12 X 06 X 115 AND 12 X 07 X 115)
K961939
Johnson & Johnson Professionals, Inc.
Orthopedic · 85d
Cleared Jun 21, 1996
FENNING FEMORAL COMPONENT
K960303
Biomet, Inc.
Orthopedic · 151d
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 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 22, 1996
BETA HIP PROSTHESIS
K953337
Zimmer, Inc.
Orthopedic · 189d
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 Nov 30, 1995
EXTEND HIP SYSTEM
K954288
Wrightmedicaltechnologyinc
Orthopedic · 77d
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