LZO · Class II · 21 CFR 888.3353

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
385–408 of 531
Cleared Jan 07, 1994
SL-PLUS & SLR-PLUS STEMS W/BIOLOX CERAMIC HEADS
K930963
Encore Orthopedics, Inc.
Orthopedic · 317d
Cleared Jun 22, 1993
WALKER HIP PROSTHESIS
K915222
Zimmer, Inc.
Orthopedic · 580d
Cleared Jun 14, 1993
TOTAL HIP PROTHESIS FEMORAL COMPONENT
K923734
Intermedics Orthopedics
Orthopedic · 322d
Cleared May 05, 1993
INFINITY(R) COLLARLESS/MICROTAPER TROCHANTERIC MOD
K920968
Dow Corning Wright
Orthopedic · 429d
Cleared Apr 20, 1993
OMNIFIT ZIRCONIA C-TAPER FEMORAL BEARING HEAD
K925695
Osteonics Corp.
Orthopedic · 159d
Cleared Feb 12, 1993
CERAMIC FEMORAL HEAD-28MM LONG, MODIFICATION
K925512
Dow Corning Wright
Orthopedic · 210d
Cleared Dec 07, 1992
ORTHOMET PERFECTA TOTAL HIP SYSTEM
K923583
Orthomet, Inc.
Orthopedic · 140d
Cleared Nov 06, 1992
PERFECTA TOTAL HIP SYSTEM, CERAMIC FEMORAL HEAD
K921836
Orthomet, Inc.
Orthopedic · 203d
Cleared Nov 04, 1992
ZIRCONIA CERAMIC MODULAR HEAD 9TYPE II TAPER
K915641
Biomet, Inc.
Orthopedic · 323d
Cleared Oct 20, 1992
OSTEONICS ZIRCONIA C-TAPER FEMORAL BEARING HEAD
K915396
Osteonics Corp.
Orthopedic · 326d
Cleared Oct 15, 1992
BIOPRO DRG CUSTOM HIP REPLACEMENT SYSTEM
K920145
Biopro, Inc.
Orthopedic · 276d
Cleared Aug 31, 1992
CERAMIC FEMORAL HEAD
K920593
Dow Corning Wright
Orthopedic · 202d
Cleared May 15, 1992
HOWEDICA ZIRCONIA FEMORAL HEAD
K920577
Howmedica Corp.
Orthopedic · 95d
Cleared Jan 16, 1992
ZIRCONIA CERAMIC MODULAR HEADS(TYPE I TAPER) MODIF
K913420
Biomet, Inc.
Orthopedic · 175d
Cleared Jan 13, 1992
EXACTECH CERAMIC FEMORAL HEAD COMPONENT
K914574
Exactech, Inc.
Orthopedic · 90d
Cleared Jan 13, 1992
ZIMMER(R) CERAMIC FEMORAL HEADS 28MM DIAMETER
K914676
Zimmer, Inc.
Orthopedic · 87d
Cleared Nov 27, 1991
BIOPRO ZIRALLOY MODULAR FEMORAL HEADS
K912641
Biopro, Inc.
Orthopedic · 166d
Cleared Nov 22, 1991
TOTAL HIP PROSTHESIS- FEMORAL COMPONENTS
K913633
Intermedics Orthopedics
Orthopedic · 99d
Cleared Apr 15, 1991
ZIRCONIA CERAMIC MODULAR HEADS
K905687
Biomet, Inc.
Orthopedic · 117d
Cleared Mar 07, 1991
ZIMMER CERAMIC FEMORAL HEADS
K905739
Zimmer, Inc.
Orthopedic · 73d
Cleared Jan 30, 1991
TOTAL HIP FEMORAL COMPONENT
K905260
Intermedics Orthopedics
Orthopedic · 70d
Cleared Jan 14, 1991
DCW MODULAR PROXIMAL FEMORAL SYSTEM
K904028
Dow Corning Wright
Orthopedic · 136d
Cleared Aug 09, 1990
OSTEONICS PS HEAD AND NECK HIP STEM SERIES
K902712
Osteonics Corp.
Orthopedic · 50d
Cleared May 09, 1990
MODULAR HIP SYSTEM
K900628
Richards Medical Co., Inc.
Orthopedic · 90d