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
Dec 19, 2001
ZIRCONIA CERAMIC FEMORAL HEAD - 12/14 TAPER
Smith & Nephew, Inc.
Orthopedic
15d
Cleared
Oct 03, 2001
PRO-FEMUR
Wrightmedicaltechnologyinc
Orthopedic
90d
Cleared
Mar 20, 2001
PORTRAIT FEMORAL COMPONENT
Biomet, Inc.
Orthopedic
22d
Cleared
Nov 30, 2000
V-40/C-TAPER ADAPTER SLEEVE
Howmedica Osteonics Corp.
Orthopedic
30d
Cleared
Nov 28, 2000
OSTEONICS ALUMINA C-TAPER HEAD
Howmedica Osteonics Corp.
Orthopedic
28d
Cleared
Nov 24, 2000
ALUMINA V40 HEAD
Howmedica Osteonics Corp.
Orthopedic
22d
Cleared
Sep 14, 2000
ACCOLADE C FEMORAL COMPONENT
Howmedica Osteonics Corp.
Orthopedic
45d
Cleared
Aug 04, 2000
TRIDENT ACETABULAR SHELLS: PS
Howmedica Osteonics Corp.
Orthopedic
87d
Cleared
Feb 15, 2000
PLR SPLINED REVISION STEM
Biomet, Inc.
Orthopedic
67d
Cleared
Feb 11, 2000
EXETER CERAMIC FEMORAL HEADS
Howmedica Osteonics Corp.
Orthopedic
87d
Cleared
Jan 28, 2000
BIOLOX ALUMINA CERAMIC FEMORAL HEAD
Smith & Nephew, Inc.
Orthopedic
296d
Cleared
Jul 30, 1999
ZIRCONIA 22.22MM CERAMIC MODULAR HEADS
Biomet, Inc.
Orthopedic
72d
Cleared
Jun 29, 1999
OSTEONICS ALUMINA C-TAPER HEAD, OSTEONICS TRIDENT POLYETHYLENE INSERTS
Howmedica Osteonics Corp.
Orthopedic
19d
Cleared
Dec 22, 1998
TYPE 3 FEMORAL COMPONENTS
Howmedica Corp.
Orthopedic
85d
Cleared
Jul 17, 1998
BIOLOX ALUMINA CERAMIC FEMORAL HEAD
Smith & Nephew, Inc.
Orthopedic
52d
Cleared
May 29, 1998
OSTEOLOCK ACETABULAR CUP
Howmedica Corp.
Orthopedic
57d
Cleared
Nov 03, 1997
PARTNERSHIP REVISION FEMORAL STEMS
Howmedica Corp.
Orthopedic
90d
Cleared
Oct 15, 1997
ZIRCONIA CERAMIC FEMORAL HEAD
Zimmer, Inc.
Orthopedic
90d
Cleared
Aug 11, 1997
ZIRCONIA CERAMIC MODULAR HEADS (NORTON ADVANCED CERAMICS)
Biomet, Inc.
Orthopedic
279d
Cleared
Jul 30, 1997
ZIRCONIA CERAMIC FEMORAL HEAD (12/14 TAPER)
Zimmer, Inc.
Orthopedic
79d
Cleared
Apr 09, 1997
RELIANCE PF FEMORAL STEMS
Howmedica Corp.
Orthopedic
78d
Cleared
Jan 24, 1997
DEPUY/ACE MODIFIED MEDICAL ASPECT (MMA) FRACTURE STEM
Depuy, Inc.
Orthopedic
60d
Cleared
Jan 14, 1997
BRIDGE LONG STEM FEMORAL COMPONENT
Wrightmedicaltechnologyinc
Orthopedic
82d
Cleared
Oct 08, 1996
ZIMMER ZIRCONIA CERAMIC FEMORAL HEAD
Zimmer, Inc.
Orthopedic
287d