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 Howmedica Osteonics Corp..

531
Total
531
Cleared
144d
Avg days
1985
Since
531 devices
481–504 of 531
Cleared Nov 22, 1991
TOTAL HIP PROSTHESIS- FEMORAL COMPONENTS
K913633
Intermedics Orthopedics
Orthopedic · 99d
Cleared Aug 12, 1991
KINAMED ATH 28MM ALUMINA CERAMIC LONG-NECK BALL
K912295
Kinamed, Inc.
Orthopedic · 82d
Cleared Apr 15, 1991
ZIRCONIA CERAMIC MODULAR HEADS
K905687
Biomet, Inc.
Orthopedic · 117d
Cleared Apr 12, 1991
FELDMUEHLE CERAMIC HEAD (12/14 X 28MM)
K910547
Turnkey Intergration USA, Inc.
Orthopedic · 64d
Cleared Apr 09, 1991
FELDMUEHLE CERAMIC HEAD (12/14 X 32MM)
K910548
Turnkey Intergration USA, Inc.
Orthopedic · 61d
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 Jan 09, 1991
CTH STABILO TOTAL HIP REPLACEMENT SYSTEM
K903976
Kinamed, Inc.
Orthopedic · 134d
Cleared Aug 09, 1990
OSTEONICS PS HEAD AND NECK HIP STEM SERIES
K902712
Osteonics Corp.
Orthopedic · 50d
Cleared Jun 08, 1990
KINAMED CEMENTED ATH-LONG STEM
K902073
Kinamed, Inc.
Orthopedic · 32d
Cleared Jun 08, 1990
KINAMED CEMENTED CTH STEM
K902074
Kinamed, Inc.
Orthopedic · 32d
Cleared May 09, 1990
MODULAR HIP SYSTEM
K900628
Richards Medical Co., Inc.
Orthopedic · 90d
Cleared Mar 19, 1990
KINAMED CERAMIC ATH TOTAL HIP - 28MM BALL
K894904
Kinamed, Inc.
Orthopedic · 230d
Cleared Dec 14, 1989
KIM MODULAR FEMORAL HIP PROSTHESIS
K895399
Dow Corning Wright
Orthopedic · 98d
Cleared Nov 20, 1989
ZIRCONIA CERAMIC HEAD ADD'L SIZES
K896204
Richards Medical Co., Inc.
Orthopedic · 25d
Cleared Oct 12, 1989
OMNIFIT CERAMIC MORSE TAPER HEAD
K894694
Osteonics Corp.
Orthopedic · 80d
Cleared Sep 26, 1989
CERAMIC FEMORAL HEAD
K893685
Dow Corning Wright
Orthopedic · 133d
Cleared Sep 01, 1989
ZIRCONIA CERAMIC HEAD (YITRIA STABILIZED)
K885069
Richards Medical Co., Inc.
Orthopedic · 267d
Cleared Sep 01, 1989
ATH CERAMIC UHMWPE TOTAL HIP SYSTEM
K890472
Kinamed, Inc.
Orthopedic · 214d
Cleared Jun 22, 1989
OMNIFIT CERAMIC MORSE TAPER HEAD (1002 SERIES)
K885102
Osteonics Corp.
Orthopedic · 192d
Cleared Jun 09, 1989
CERAMIC TOTAL HIP BALL HEAD, LARGE TAPER
K891082
Depuy, Inc.
Orthopedic · 100d
Cleared Jun 09, 1989
CERAMIC TOTAL HIP BALL HEAD, SMALL TAPER
K891083
Depuy, Inc.
Orthopedic · 100d
Cleared May 10, 1989
VARIOUS FEMORAL HIP PROSTHESES W/SELF LOCK CERAMIC
K884952
Protek, Inc.
Orthopedic · 162d