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..
531
Total
531
Cleared
144d
Avg days
1985
Since
531 devices
Cleared
Jan 07, 1994
SL-PLUS & SLR-PLUS STEMS W/BIOLOX CERAMIC HEADS
Encore Orthopedics, Inc.
Orthopedic
317d
Cleared
Jun 22, 1993
WALKER HIP PROSTHESIS
Zimmer, Inc.
Orthopedic
580d
Cleared
Jun 14, 1993
TOTAL HIP PROTHESIS FEMORAL COMPONENT
Intermedics Orthopedics
Orthopedic
322d
Cleared
May 05, 1993
INFINITY(R) COLLARLESS/MICROTAPER TROCHANTERIC MOD
Dow Corning Wright
Orthopedic
429d
Cleared
Apr 20, 1993
OMNIFIT ZIRCONIA C-TAPER FEMORAL BEARING HEAD
Osteonics Corp.
Orthopedic
159d
Cleared
Feb 12, 1993
CERAMIC FEMORAL HEAD-28MM LONG, MODIFICATION
Dow Corning Wright
Orthopedic
210d
Cleared
Dec 07, 1992
ORTHOMET PERFECTA TOTAL HIP SYSTEM
Orthomet, Inc.
Orthopedic
140d
Cleared
Nov 06, 1992
PERFECTA TOTAL HIP SYSTEM, CERAMIC FEMORAL HEAD
Orthomet, Inc.
Orthopedic
203d
Cleared
Nov 04, 1992
ZIRCONIA CERAMIC MODULAR HEAD 9TYPE II TAPER
Biomet, Inc.
Orthopedic
323d
Cleared
Oct 20, 1992
OSTEONICS ZIRCONIA C-TAPER FEMORAL BEARING HEAD
Osteonics Corp.
Orthopedic
326d
Cleared
Oct 15, 1992
BIOPRO DRG CUSTOM HIP REPLACEMENT SYSTEM
Biopro, Inc.
Orthopedic
276d
Cleared
Aug 31, 1992
CERAMIC FEMORAL HEAD
Dow Corning Wright
Orthopedic
202d
Cleared
May 15, 1992
HOWEDICA ZIRCONIA FEMORAL HEAD
Howmedica Corp.
Orthopedic
95d
Cleared
Jan 16, 1992
ZIRCONIA CERAMIC MODULAR HEADS(TYPE I TAPER) MODIF
Biomet, Inc.
Orthopedic
175d
Cleared
Jan 13, 1992
EXACTECH CERAMIC FEMORAL HEAD COMPONENT
Exactech, Inc.
Orthopedic
90d
Cleared
Jan 13, 1992
ZIMMER(R) CERAMIC FEMORAL HEADS 28MM DIAMETER
Zimmer, Inc.
Orthopedic
87d
Cleared
Nov 27, 1991
BIOPRO ZIRALLOY MODULAR FEMORAL HEADS
Biopro, Inc.
Orthopedic
166d
Cleared
Nov 22, 1991
TOTAL HIP PROSTHESIS- FEMORAL COMPONENTS
Intermedics Orthopedics
Orthopedic
99d
Cleared
Apr 15, 1991
ZIRCONIA CERAMIC MODULAR HEADS
Biomet, Inc.
Orthopedic
117d
Cleared
Mar 07, 1991
ZIMMER CERAMIC FEMORAL HEADS
Zimmer, Inc.
Orthopedic
73d
Cleared
Jan 30, 1991
TOTAL HIP FEMORAL COMPONENT
Intermedics Orthopedics
Orthopedic
70d
Cleared
Jan 14, 1991
DCW MODULAR PROXIMAL FEMORAL SYSTEM
Dow Corning Wright
Orthopedic
136d
Cleared
Aug 09, 1990
OSTEONICS PS HEAD AND NECK HIP STEM SERIES
Osteonics Corp.
Orthopedic
50d
Cleared
May 09, 1990
MODULAR HIP SYSTEM
Richards Medical Co., Inc.
Orthopedic
90d