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 Smith & Nephew, Inc..

564
Total
564
Cleared
152d
Avg days
1984
Since
564 devices
409–432 of 564
Cleared Jan 28, 1998
FOUNDATION POROUS ACETABULAR SYSTEM
K973119
Encore Orthopedics, Inc.
Orthopedic · 161d
Cleared Jan 28, 1998
FOUNDATION POROUS COATED HEMISPHERICAL SHELL
K974093
Encore Orthopedics, Inc.
Orthopedic · 90d
Cleared Jan 28, 1998
FOUNDATION POROUS COATED FLARED RIM SHELL
K974095
Encore Orthopedics, Inc.
Orthopedic · 90d
Cleared Jan 12, 1998
ENCORE LINEAR POROUS COATED HIP
K974294
Encore Orthopedics, Inc.
Orthopedic · 59d
Cleared Dec 24, 1997
VERSYS HIP SYSTEM BEADED HIP PROSTHESIS
K973714
Zimmer, Inc.
Orthopedic · 86d
Cleared Dec 19, 1997
NATURAL-HIP POROUS STEM WITH OFFSET
K973675
Sulzer Orthopedics, Inc.
Orthopedic · 84d
Cleared Dec 19, 1997
REVELATION POROUS HIP STEM
K973685
Encore Orthopedics, Inc.
Orthopedic · 84d
Cleared Dec 04, 1997
REACH FEMORAL HIP COMPONENT
K971824
Biomet, Inc.
Orthopedic · 202d
Cleared Dec 02, 1997
FOUNDATION POROUS HIP STEM
K973302
Encore Orthopedics, Inc.
Orthopedic · 90d
Cleared Nov 21, 1997
ACETABULAR SHELLS WITH MESH INGROWTH SURFACE
K973163
Howmedica Corp.
Orthopedic · 88d
Cleared Nov 12, 1997
DEPUY DURALOC ACETABULAR CUP SYSTEM
K972596
Depuy, Inc.
Orthopedic · 124d
Cleared Nov 03, 1997
APR POROUS HA HIP SYSTEM
K973124
Sulzer Orthopedics, Inc.
Orthopedic · 75d
Cleared Oct 24, 1997
SMC ACETABULAR COMPONENT
K971018
Signal Medical Corp.
Orthopedic · 218d
Cleared Oct 16, 1997
INFINTY DISTAL FEMORAL COMPONENT
K973530
Wrightmedicaltechnologyinc
Orthopedic · 28d
Cleared Sep 19, 1997
INTER-OP HA POROUS ACETABULAR SYSTEM (HA/CSTI)
K972393
Sulzer Orthopedics, Inc.
Orthopedic · 85d
Cleared Aug 14, 1997
DEPUY PROXIMAL FEMORAL REPLACEMENT PROSTHESIS
K970241
Depuy, Inc.
Orthopedic · 204d
Cleared Aug 07, 1997
QUATROLOC PLASMA SPRAYED FEMORAL COMPONENT
K964616
Whiteside Biomechanics, Inc.
Orthopedic · 287d
Cleared Jul 30, 1997
OSTEOLOCK ACETABULAR SHELL SYSTEM
K971854
Howmedica Corp.
Orthopedic · 71d
Cleared Jul 23, 1997
MICRO-SEAL ACETABULAR SYSTEM
K971718
Whiteside Biomechanics, Inc.
Orthopedic · 75d
Cleared Jul 09, 1997
INTERSEAL ACETABULAR SCREW HOLE PLUG
K971429
Wrightmedicaltechnologyinc
Orthopedic · 82d
Cleared Jul 03, 1997
NATURAL-HIP SYSTEM POROUS STEM WITH HA/CSTI
K970300
Intermedics Orthopedics
Orthopedic · 160d
Cleared Jun 19, 1997
IMPLEX A-240 HEP ACETABULAR CUP SYSTEM
K964509
Implex Corp.
Orthopedic · 223d
Cleared Jun 19, 1997
TCP-COATED POROCOAT AML FEMORAL HIP PROSTHESIS
K964650
Depuy, Inc.
Orthopedic · 211d
Cleared Jun 18, 1997
LSF TRIAD TOTAL HIP SYSTEM
K971020
Osteoimplant Technology, Inc.
Orthopedic · 90d