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 Smith & Nephew, Inc., Howmedica Osteonics Corp. and Medacta International S.A..

529
Total
529
Cleared
144d
Avg days
1985
Since
529 devices
217–240 of 529
Cleared Feb 16, 1996
BIMETRIC COCR HEAD/NECK REPLACEMENT HIP STEM
K955350
Biomet, Inc.
Orthopedic · 87d
Cleared Jan 31, 1996
FINE GRAIN CAST COBALT CHROMIUM HIP STEMS
K953925
Biomet, Inc.
Orthopedic · 166d
Cleared Oct 20, 1995
ZIRCONIA CERAMIC FEMORAL HEAD
K944689
Wrightmedicaltechnologyinc
Orthopedic · 393d
Cleared Sep 19, 1995
BUCHALTER FAUSER FEMORAL COMPONENTS
K952686
Biomet, Inc.
Orthopedic · 99d
Cleared Jul 03, 1995
V40 ZIRCONIA FEMORAL HEADS
K952418
Howmedica Corp.
Orthopedic · 41d
Cleared Jun 30, 1995
ZIRCONIA ARTICUL/EZE FEMORAL BALLS
K952088
Depuy, Inc.
Orthopedic · 58d
Cleared Jan 19, 1995
SENTRY TOTAL HIP
K945089
Howmedica Corp.
Orthopedic · 94d
Cleared Jan 19, 1995
HOWMEDICA ZIRCONIA CERAMIC FEMORAL HEAD
K945090
Howmedica Corp.
Orthopedic · 94d
Cleared Jan 19, 1995
P.C.A.PRIMARY HIP- CEMENTLESS USE
K945092
Howmedica Corp.
Orthopedic · 94d
Cleared Jan 19, 1995
HNR-PC HIP
K945094
Howmedica Corp.
Orthopedic · 94d
Cleared Jan 19, 1995
APC FEMORAL COMPONENT
K945095
Howmedica Corp.
Orthopedic · 94d
Cleared Jan 19, 1995
CDH HIP STEM
K945096
Howmedica Corp.
Orthopedic · 94d
Cleared Jan 18, 1995
HOWMEDICA ALUMINA FEMORAL HEAD
K945091
Howmedica Corp.
Orthopedic · 93d
Cleared Jan 12, 1995
ZIMMER ZIRCONIA CERAMIC FEMORAL HEAD
K944601
Zimmer, Inc.
Orthopedic · 115d
Cleared Oct 17, 1994
ZIRCONIA CERAMIC MODULAR HEADS (ASTRO MET)
K943586
Biomet, Inc.
Orthopedic · 87d
Cleared Oct 14, 1994
SOLUTION BOWED FEMORAL HIP PROTSTHESIS
K933942
Depuy, Inc.
Orthopedic · 428d
Cleared Jul 12, 1994
5/8 POROCOAT AML HIP POROCOAT POROUS COATING
K941847
Depuy, Inc.
Orthopedic · 89d
Cleared Jul 12, 1994
SOLUTION HIP
K941942
Depuy, Inc.
Orthopedic · 82d
Cleared Jul 06, 1994
STABILITY HIP STEM WITH POROCOAT
K934457
Depuy, Inc.
Orthopedic · 296d
Cleared Mar 10, 1994
ZICONIA CERAMIC MOD HEAD(TYPE I TAPER 28/32, +6MM)
K925345
Biomet, Inc.
Orthopedic · 504d
Cleared Mar 10, 1994
ELITE(TM) ZIRCONIA TOTAL HIP BALL HEAD SYSTEM
K926395
Depuy, Inc.
Orthopedic · 444d
Cleared Feb 16, 1994
MALLORY-HEAD TOTAL HIP SYSTEM
K921181
Biomet, Inc.
Orthopedic · 708d
Cleared Feb 16, 1994
BIMETRIC TOTAL HIP SYSTEM
K921224
Biomet, Inc.
Orthopedic · 705d
Cleared Feb 16, 1994
INTEGRAL TOTAL HIP SYSTEM
K921225
Biomet, Inc.
Orthopedic · 705d