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
265–288 of 561
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 Jul 21, 1995
VITALOCK SOLID BACKED ACETABULAR SHELL
K952397
Howmedica Corp.
Orthopedic · 60d
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 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
Cleared Apr 18, 1995
DEPUY DURALOC CEMENTLESS ACETABULAR CUP SYSTEM
K951301
Depuy, Inc.
Orthopedic · 27d
Cleared Mar 07, 1995
BIAS(TM) FIBER METAL TOTAL HIP STEM (TFB)
K934515
Zimmer, Inc.
Orthopedic · 538d
Cleared Dec 21, 1994
APOGEE HIP STEM WITH POROCOAT
K934334
Depuy, Inc.
Orthopedic · 470d
Cleared Sep 28, 1994
PRECISION OSTELOCK SP FEMORAL COMPONENT
K941141
Howmedica Corp.
Orthopedic · 202d
Cleared Sep 28, 1994
INFINITY REVISION HIP STEM
K942115
Wrightmedicaltechnologyinc
Orthopedic · 148d
Cleared May 16, 1994
HOWMEDICA ACETABULAR SHELL W/SCREW HOLES
K933102
Howmedica Corp.
Orthopedic · 326d
Cleared Apr 29, 1994
TRILOGY ACETABULAR SYSTEM
K934765
Zimmer, Inc.
Orthopedic · 206d
Cleared Apr 13, 1994
POROCOAT POROUS COATING/AML PROXIMALLY-COATED STEM
K933787
Depuy, Inc.
Orthopedic · 252d
Cleared Mar 21, 1994
POROCOAT POROUS COATING
K931641
Depuy, Inc.
Orthopedic · 353d
Cleared Mar 03, 1994
ACETABULAR SHELL
K935731
Howmedica Corp.
Orthopedic · 92d
Cleared Feb 22, 1994
HG MULTILOCK HIP PROSTHESIS W/ TI-NIDIUM
K921308
Zimmer, Inc.
Orthopedic · 705d
Cleared Feb 22, 1994
BIAS TOTAL HIP SYSTEM ACETABULAR COMPONENT
K921557
Zimmer, Inc.
Orthopedic · 692d
Cleared Feb 22, 1994
ZIMMER ANATOMIC HIP SYSTEM
K922071
Zimmer, Inc.
Orthopedic · 659d
Cleared Feb 22, 1994
PCA(R) E SERIES HIP SYSTEM (CEMENTLESS USE)
K925172
Howmedica Corp.
Orthopedic · 496d
Cleared Feb 16, 1994
RANAWAT/BURSTEIN TOTAL HIP SYSTEM
K921277
Biomet, Inc.
Orthopedic · 701d
Cleared Feb 16, 1994
TAPERLOC FEMORAL STEM AND UNIVERSAL ACETABULAR COM
K921301
Biomet, Inc.
Orthopedic · 700d