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 Zimmer, Inc..
534
Total
534
Cleared
144d
Avg days
1985
Since
534 devices
Cleared
Nov 23, 1999
ZYRANOX ZIRCONIA CERAMIC FEMORAL HEADS
Corin USA
Orthopedic
144d
Cleared
Sep 22, 1999
BIOPRO RIMMED ACETABULAR COMPOMENT
Biologically Oriented Prostheses
Orthopedic
90d
Cleared
Aug 27, 1999
PLUS CERAMIC HEAD PROSTHESES (ALUMINA AND ZIRKONIA)
Plus Orthopedics
Orthopedic
212d
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
Jun 11, 1999
IMPLEX ALUMINA FEMORAL HEAD
Implex Corp.
Orthopedic
142d
Cleared
Jun 01, 1999
FOUNDATION POROUS HIP STEM
Encore Orthopedics, Inc.
Orthopedic
50d
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
Jun 25, 1998
SMC 28MM CERAMIC FEMORAL HEADS
Signal Medical Corp.
Orthopedic
77d
Cleared
May 29, 1998
OSTEOLOCK ACETABULAR CUP
Howmedica Corp.
Orthopedic
57d
Cleared
Apr 29, 1998
OSTEONICS GAP-II RESTORATION ACETABULAR SHELLS
Osteonics Corp.
Orthopedic
58d
Cleared
Apr 16, 1998
PARTNERSHIP CALCAR FEMORAL COMPONENTS
Howmedica, Inc.
Orthopedic
83d
Cleared
Apr 16, 1998
PRESS-FIT STEM
Encore Orthopedics, Inc.
Orthopedic
69d
Cleared
Apr 09, 1998
S-ROM ZIRCONIA CERAMIC FEMORAL HIP HEAD
Johnson & Johnson Professionals, Inc.
Orthopedic
90d
Cleared
Jan 06, 1998
CLS STEM, WAGNER REVISION STEM, ALLOCLASSIC ZWEYMULLER STEM, SL
Sulzer Orthopedics, Inc.
Orthopedic
90d
Cleared
Dec 19, 1997
NATURAL-HIP COCR OFFSET STEM
Sulzer Orthopedics, Inc.
Orthopedic
84d
Cleared
Dec 05, 1997
MERIDIAN TITANIUM FEMORAL STEMS
Howmedica, Inc.
Orthopedic
175d
Cleared
Nov 24, 1997
WHITESIDE BIOMECHANICS, INC. CERAMIC UNIPOLAR FEMORAL HEAD
Whiteside Biomechanics, Inc.
Orthopedic
87d
Cleared
Nov 20, 1997
S-ROM ZIRCONIA CERAMIC FEMORAL HIP HEAD
Johnson & Johnson Professionals, Inc.
Orthopedic
78d
Cleared
Nov 14, 1997
MOST HEX INTRAMEDULLARY (I/M) STEM
Sulzer Orthopedics, Inc.
Orthopedic
88d
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
Oct 01, 1997
PRECEDENT REVISION HIP SYSTEM
Sulzer Orthopedics, Inc.
Orthopedic
78d