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..
534
Total
534
Cleared
144d
Avg days
1985
Since
534 devices
Cleared
Dec 13, 2001
ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTS
Sulzer Orthopedics, Inc.
Orthopedic
15d
Cleared
Nov 27, 2001
APEX MODULAR ALUMINA FEMORAL HEAD
Apex Surgical, LLC
Orthopedic
89d
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
APEX MODULAR ZIRCONIA FEMORAL HEAD
Apex Surgical, LLC
Orthopedic
90d
Cleared
Mar 20, 2001
PORTRAIT FEMORAL COMPONENT
Biomet, Inc.
Orthopedic
22d
Cleared
Jan 19, 2001
OTI CERAMIC FEMORAL HEAD SYSTEM
Osteoimplant Technology, Inc.
Orthopedic
88d
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
Cleared
Aug 04, 2000
TRIDENT ACETABULAR SHELLS: PS
Howmedica Osteonics Corp.
Orthopedic
87d
Cleared
Jun 05, 2000
BOFOR REVISION COUP
Plus Orthopedics
Orthopedic
203d
Cleared
Apr 24, 2000
RESPONSE 2000 HIP STEM
DePuy Orthopaedics, Inc.
Orthopedic
77d
Cleared
Apr 24, 2000
RESPONSE 2000 CEMENTED HIP STEM
DePuy Orthopaedics, Inc.
Orthopedic
75d
Cleared
Feb 18, 2000
MRS-TITAN
Rotec Medizintechnik GmbH
Orthopedic
219d
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
Jan 21, 2000
MRP-TITAN
Rotec Medizintechnik GmbH
Orthopedic
186d
Cleared
Dec 02, 1999
MS-30 FEMORAL STEM
Sulzer Orthopedics, Inc.
Orthopedic
83d