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
481–504 of 564
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
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 Apr 14, 1995
ZTT I AND II ACETABULAR CUP OF THE S-ROM TOTAL HIP SYSTEM
K951000
Joint Medical Products Corp.
Orthopedic · 42d
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 Jun 03, 1994
COATED ZT PROXIMAL SLEEVE
K934412
Joint Medical Products Corp.
Orthopedic · 266d
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