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
385–408 of 562
Cleared Apr 18, 1995
PROFORM POROUS ACETABULAR ASSEMBLY
K950827
Stelkast Company
Orthopedic · 54d
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 Oct 14, 1994
ORTHOMET ACETABULAR CUP SYSTEM
K931333
Orthomet, Inc.
Orthopedic · 577d
Cleared Oct 04, 1994
OSTEONICS SECURE-FIT AD ACETABULAR COMPONENT SYSTEM
K943054
Osteonics Corp.
Orthopedic · 99d
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 Jul 29, 1994
OSTEONICS SCREWLESS ACETABULAR COMPONENTS
K935875
Osteonics Corp.
Orthopedic · 232d
Cleared Jun 06, 1994
PROVIDENT HIP SYSTEM
K935484
Stelkast Company
Orthopedic · 203d
Cleared May 16, 1994
HOWMEDICA ACETABULAR SHELL W/SCREW HOLES
K933102
Howmedica Corp.
Orthopedic · 326d
Cleared May 12, 1994
IMPLEX A-230 POROUS ACETABULAR CUP SYST. CEMENTED
K932924
Implex Corp.
Orthopedic · 331d
Cleared May 06, 1994
REFLECTION ACETABULAR COMPONENT
K932755
Smith & Nephew Richards, Inc.
Orthopedic · 350d
Cleared May 03, 1994
IMPLEX A-230 POROUS ACETABULAR CUP SYST.CEMENTLESS
K932923
Implex Corp.
Orthopedic · 322d
Cleared Apr 29, 1994
RMHS MONOLITHIC FEMORAL COMPONENT
K931642
Smith & Nephew Richards, Inc.
Orthopedic · 392d
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