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
Jul 01, 2003
DEPUY CERAMIC FEMORAL HEADS
DePuy Orthopaedics, Inc.
Orthopedic
20d
Cleared
Jun 03, 2003
ALUMINA CERAMIC FEMORAL HEADS, 28 AND 32 MM
Zimmer, Inc.
Orthopedic
88d
Cleared
Jan 28, 2003
ALUMINA V40 FEMORAL HEADS
Howmedica Osteonics Corp.
Orthopedic
67d
Cleared
Dec 05, 2002
ASCENDENT ACETABULAR SYSTEM
Sulzer Orthopedics, Inc.
Orthopedic
87d
Cleared
Oct 17, 2002
GMRS PRESS FIT STEMS WITH PUREFIX HA
Howmedica Osteonics Corp.
Orthopedic
86d
Cleared
Sep 23, 2002
RESTORATION MODULAR SYSTEM
Howmedica Osteonics Corp.
Orthopedic
53d
Cleared
Aug 26, 2002
ACCOLADE C FEMORAL STEMS
Howmedica Osteonics Corp.
Orthopedic
24d
Cleared
Jul 24, 2002
MPF ACETABULAR CUP GENERATION 2
Plus Orthopedics
Orthopedic
23d
Cleared
Jun 11, 2002
TOTAL HIP FEMORAL HEAD - 12/14 TAPER
Smith & Nephew, Inc.
Orthopedic
21d
Cleared
May 14, 2002
MS-30 LATERAL FEMORAL STEM
Sulzer Orthopedics, Inc.
Orthopedic
70d
Cleared
Apr 03, 2002
2 PIECE MODULAR HIP STEM
Howmedica Osteonics Corp.
Orthopedic
198d
Cleared
Jan 28, 2002
DEPUY FEMORAL HEADS
DePuy Orthopaedics, Inc.
Orthopedic
255d
Cleared
Dec 19, 2001
ZIRCONIA CERAMIC FEMORAL HEAD - 12/14 TAPER
Smith & Nephew, Inc.
Orthopedic
15d
Cleared
Dec 13, 2001
ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTS
Sulzer Orthopedics, Inc.
Orthopedic
15d
Cleared
Oct 03, 2001
PRO-FEMUR
Wrightmedicaltechnologyinc
Orthopedic
90d
Cleared
Sep 07, 2001
MPF ACETABULAR CUP
Plus Orthopedics
Orthopedic
87d
Cleared
Apr 18, 2001
CLS VARUS STEM/CLS 135 STEM
Sulzer Orthopedics, Inc.
Orthopedic
28d
Cleared
Apr 06, 2001
LPC-PLUS ACETABULAR CUP
Plus Orthopedics
Orthopedic
170d
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
Sep 01, 2000
FENNING HIP STEM
DePuy Orthopaedics, Inc.
Orthopedic
23d