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 Smith & Nephew, Inc., Howmedica Osteonics Corp. and Medacta International S.A..
529
Total
529
Cleared
144d
Avg days
1985
Since
529 devices
Cleared
Feb 16, 1996
BIMETRIC COCR HEAD/NECK REPLACEMENT HIP STEM
Biomet, Inc.
Orthopedic
87d
Cleared
Jan 31, 1996
FINE GRAIN CAST COBALT CHROMIUM HIP STEMS
Biomet, Inc.
Orthopedic
166d
Cleared
Oct 20, 1995
ZIRCONIA CERAMIC FEMORAL HEAD
Wrightmedicaltechnologyinc
Orthopedic
393d
Cleared
Sep 19, 1995
BUCHALTER FAUSER FEMORAL COMPONENTS
Biomet, Inc.
Orthopedic
99d
Cleared
Jul 03, 1995
V40 ZIRCONIA FEMORAL HEADS
Howmedica Corp.
Orthopedic
41d
Cleared
Jun 30, 1995
ZIRCONIA ARTICUL/EZE FEMORAL BALLS
Depuy, Inc.
Orthopedic
58d
Cleared
Jan 19, 1995
SENTRY TOTAL HIP
Howmedica Corp.
Orthopedic
94d
Cleared
Jan 19, 1995
HOWMEDICA ZIRCONIA CERAMIC FEMORAL HEAD
Howmedica Corp.
Orthopedic
94d
Cleared
Jan 19, 1995
P.C.A.PRIMARY HIP- CEMENTLESS USE
Howmedica Corp.
Orthopedic
94d
Cleared
Jan 19, 1995
HNR-PC HIP
Howmedica Corp.
Orthopedic
94d
Cleared
Jan 19, 1995
APC FEMORAL COMPONENT
Howmedica Corp.
Orthopedic
94d
Cleared
Jan 19, 1995
CDH HIP STEM
Howmedica Corp.
Orthopedic
94d
Cleared
Jan 18, 1995
HOWMEDICA ALUMINA FEMORAL HEAD
Howmedica Corp.
Orthopedic
93d
Cleared
Jan 12, 1995
ZIMMER ZIRCONIA CERAMIC FEMORAL HEAD
Zimmer, Inc.
Orthopedic
115d
Cleared
Oct 17, 1994
ZIRCONIA CERAMIC MODULAR HEADS (ASTRO MET)
Biomet, Inc.
Orthopedic
87d
Cleared
Oct 14, 1994
SOLUTION BOWED FEMORAL HIP PROTSTHESIS
Depuy, Inc.
Orthopedic
428d
Cleared
Jul 12, 1994
5/8 POROCOAT AML HIP POROCOAT POROUS COATING
Depuy, Inc.
Orthopedic
89d
Cleared
Jul 12, 1994
SOLUTION HIP
Depuy, Inc.
Orthopedic
82d
Cleared
Jul 06, 1994
STABILITY HIP STEM WITH POROCOAT
Depuy, Inc.
Orthopedic
296d
Cleared
Mar 10, 1994
ZICONIA CERAMIC MOD HEAD(TYPE I TAPER 28/32, +6MM)
Biomet, Inc.
Orthopedic
504d
Cleared
Mar 10, 1994
ELITE(TM) ZIRCONIA TOTAL HIP BALL HEAD SYSTEM
Depuy, Inc.
Orthopedic
444d
Cleared
Feb 16, 1994
MALLORY-HEAD TOTAL HIP SYSTEM
Biomet, Inc.
Orthopedic
708d
Cleared
Feb 16, 1994
BIMETRIC TOTAL HIP SYSTEM
Biomet, Inc.
Orthopedic
705d
Cleared
Feb 16, 1994
INTEGRAL TOTAL HIP SYSTEM
Biomet, Inc.
Orthopedic
705d