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
457–480 of 531
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 Nov 03, 1992
KINAMED 32MM BIOCERAM-Z TOATAL HIP FEMORAL BALL
K920290
Kinamed, Inc.
Orthopedic · 286d
Cleared Oct 30, 1992
KINAMED 26MM BIOCERAN-Z TOTAL HIP FEMORAL BALL
K920219
Kinamed, Inc.
Orthopedic · 288d
Cleared Oct 22, 1992
S-ROM ZIRCONIA CERMAMIC FEMORAL HEAD
K921111
Joint Medical Products Corp.
Orthopedic · 227d
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 18, 1992
FELDMUHLE CERAMIC HEAD
K920756
Link America, Inc.
Orthopedic · 89d
Cleared May 15, 1992
HOWEDICA ZIRCONIA FEMORAL HEAD
K920577
Howmedica Corp.
Orthopedic · 95d
Cleared Feb 19, 1992
KINAMED 22MM BIOCERAM-Z TOTAL HIP FEMORAL BALL
K915309
Kinamed, Inc.
Orthopedic · 89d
Cleared Feb 19, 1992
KINAMED 28MM BIOCERAM-Z TOTAL HIP FEMORAL BALL
K915310
Kinamed, Inc.
Orthopedic · 89d
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 Dec 24, 1991
LIMA 28MM CERAMIC HEAD, MODIFICATION
K912985
Turnkey Intergration USA, Inc.
Orthopedic · 175d
Cleared Dec 05, 1991
KINAMED CTN STEM
K914237
Kinamed, Inc.
Orthopedic · 76d
Cleared Nov 27, 1991
BIOPRO ZIRALLOY MODULAR FEMORAL HEADS
K912641
Biopro, Inc.
Orthopedic · 166d