FDA Product Code LZO: Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Hip replacement surgery restores mobility and eliminates pain in patients with advanced joint disease. FDA product code LZO covers semi-constrained hip prostheses with metal, ceramic, or polymer bearing surfaces.
These implants replace the femoral head and acetabular socket with engineered bearing couples designed to minimize wear and maximize longevity. Material combinations include metal-on-polyethylene, ceramic-on-ceramic, and ceramic-on-polyethylene.
LZO devices are Class II medical devices, regulated under 21 CFR 888.3353 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include Medacta International S.A., Smith & Nephew, Inc. and Howmedica Osteonics Corp..
531
Total
531
Cleared
144d
Avg days
1985
Since
531 devices
Cleared
Nov 22, 1991
TOTAL HIP PROSTHESIS- FEMORAL COMPONENTS
Intermedics Orthopedics
Orthopedic
99d
Cleared
Aug 12, 1991
KINAMED ATH 28MM ALUMINA CERAMIC LONG-NECK BALL
Kinamed, Inc.
Orthopedic
82d
Cleared
Apr 15, 1991
ZIRCONIA CERAMIC MODULAR HEADS
Biomet, Inc.
Orthopedic
117d
Cleared
Apr 12, 1991
FELDMUEHLE CERAMIC HEAD (12/14 X 28MM)
Turnkey Intergration USA, Inc.
Orthopedic
64d
Cleared
Apr 09, 1991
FELDMUEHLE CERAMIC HEAD (12/14 X 32MM)
Turnkey Intergration USA, Inc.
Orthopedic
61d
Cleared
Mar 07, 1991
ZIMMER CERAMIC FEMORAL HEADS
Zimmer, Inc.
Orthopedic
73d
Cleared
Jan 30, 1991
TOTAL HIP FEMORAL COMPONENT
Intermedics Orthopedics
Orthopedic
70d
Cleared
Jan 14, 1991
DCW MODULAR PROXIMAL FEMORAL SYSTEM
Dow Corning Wright
Orthopedic
136d
Cleared
Jan 09, 1991
CTH STABILO TOTAL HIP REPLACEMENT SYSTEM
Kinamed, Inc.
Orthopedic
134d
Cleared
Aug 09, 1990
OSTEONICS PS HEAD AND NECK HIP STEM SERIES
Osteonics Corp.
Orthopedic
50d
Cleared
Jun 08, 1990
KINAMED CEMENTED ATH-LONG STEM
Kinamed, Inc.
Orthopedic
32d
Cleared
Jun 08, 1990
KINAMED CEMENTED CTH STEM
Kinamed, Inc.
Orthopedic
32d
Cleared
May 09, 1990
MODULAR HIP SYSTEM
Richards Medical Co., Inc.
Orthopedic
90d
Cleared
Mar 19, 1990
KINAMED CERAMIC ATH TOTAL HIP - 28MM BALL
Kinamed, Inc.
Orthopedic
230d
Cleared
Dec 14, 1989
KIM MODULAR FEMORAL HIP PROSTHESIS
Dow Corning Wright
Orthopedic
98d
Cleared
Nov 20, 1989
ZIRCONIA CERAMIC HEAD ADD'L SIZES
Richards Medical Co., Inc.
Orthopedic
25d
Cleared
Oct 12, 1989
OMNIFIT CERAMIC MORSE TAPER HEAD
Osteonics Corp.
Orthopedic
80d
Cleared
Sep 26, 1989
CERAMIC FEMORAL HEAD
Dow Corning Wright
Orthopedic
133d
Cleared
Sep 01, 1989
ZIRCONIA CERAMIC HEAD (YITRIA STABILIZED)
Richards Medical Co., Inc.
Orthopedic
267d
Cleared
Sep 01, 1989
ATH CERAMIC UHMWPE TOTAL HIP SYSTEM
Kinamed, Inc.
Orthopedic
214d
Cleared
Jun 22, 1989
OMNIFIT CERAMIC MORSE TAPER HEAD (1002 SERIES)
Osteonics Corp.
Orthopedic
192d
Cleared
Jun 09, 1989
CERAMIC TOTAL HIP BALL HEAD, LARGE TAPER
Depuy, Inc.
Orthopedic
100d
Cleared
Jun 09, 1989
CERAMIC TOTAL HIP BALL HEAD, SMALL TAPER
Depuy, Inc.
Orthopedic
100d
Cleared
May 10, 1989
VARIOUS FEMORAL HIP PROSTHESES W/SELF LOCK CERAMIC
Protek, Inc.
Orthopedic
162d