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..

562
Total
562
Cleared
152d
Avg days
1984
Since
562 devices
361–384 of 562
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 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 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 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
Cleared Aug 14, 1995
OSTEONICS PS HEMI-HIP STEM SERIES
K933882
Osteonics Corp.
Orthopedic · 734d
Cleared Jul 21, 1995
VITALOCK SOLID BACKED ACETABULAR SHELL
K952397
Howmedica Corp.
Orthopedic · 60d
Cleared Jul 06, 1995
F-230 POROUS FEMORAL HIP STEM (CEMENTLESS)
K941612
Implex Corp.
Orthopedic · 458d
Cleared Jun 16, 1995
SYSTEM 12 P1 26MM ACETABULAR INSERT
K951114
Howmedica Corp.
Orthopedic · 98d
Cleared Jun 16, 1995
HOWMEDICA VITALOCK 22MM ACERTABULAR SHELL AND SYSTEM 12 INSERTS
K951115
Howmedica Corp.
Orthopedic · 98d
Cleared Jun 07, 1995
ORTHOMET HMC FEMORAL STEM COMPONENT
K936310
Orthomet, Inc.
Orthopedic · 426d
Cleared Jun 07, 1995
OSTEONICS OMNIFIT AD HIP STEM SERIES
K940715
Osteonics Corp.
Orthopedic · 474d
Cleared May 17, 1995
PRECISION OSTEOLOCK FEMORAL COMPONENT
K944592
Howmedica Corp.
Orthopedic · 240d
Cleared May 11, 1995
DEPUY DURALOC 100C ACETABULAR CUP
K951674
Depuy, Inc.
Orthopedic · 30d
Cleared Apr 27, 1995
10.5MM REPLICA HIP STEM
K951095
Depuy, Inc.
Orthopedic · 50d