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..

534
Total
534
Cleared
144d
Avg days
1985
Since
534 devices
409–432 of 534
Cleared Aug 19, 1996
ZWEYMUELLER SL FEMORAL HIP STEM
K962101
Intermedics Orthopedics
Orthopedic · 81d
Cleared Aug 05, 1996
WAGNER REVISION STEM
K960588
Intermedics Orthopedics
Orthopedic · 175d
Cleared Aug 05, 1996
APR OVERSIZED HIP STEM
K961921
Intermedics Orthopedics
Orthopedic · 80d
Cleared Jul 19, 1996
NATURAL-HIP SYSTEM - CALCAR REPLACEMENT HIP STEM
K961727
Intermedics Orthopedics
Orthopedic · 77d
Cleared Jul 09, 1996
APR FULLY TEXTURED HIP STEM
K961589
Intermedics Orthopedics
Orthopedic · 76d
Cleared Jun 07, 1996
CLS STEM (MODIFICATION)
K953690
Intermedics Orthopedics
Orthopedic · 312d
Cleared Apr 05, 1996
IMPLEX CERAMIC HEAD
K955117
Implex Corp.
Orthopedic · 148d
Cleared Feb 20, 1996
CONSENSUS ZIRCONIA FEMORAL HEAD
K955386
U.S. Medical Products, Inc.
Orthopedic · 90d
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 Jan 18, 1996
BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD
K954768
Biologically Oriented Prostheses
Orthopedic · 93d
Cleared Nov 29, 1995
CLS ACETABULAR COMPONENT (MODIFICATION)
K953688
Intermedics Orthopedics
Orthopedic · 121d
Cleared Nov 29, 1995
WAGNER REVISION STEM (MODIFICATION)
K953689
Intermedics Orthopedics
Orthopedic · 121d
Cleared Nov 06, 1995
CONSENSUS ZIRCONIA HEAD SIZE -3.5, 0, +5
K953792
U.S. Medical Products, Inc.
Orthopedic · 84d
Cleared Oct 20, 1995
ZIRCONIA CERAMIC FEMORAL HEAD
K944689
Wrightmedicaltechnologyinc
Orthopedic · 393d
Cleared Sep 27, 1995
BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD
K953045
Biologically Oriented Prostheses
Orthopedic · 89d
Cleared Sep 19, 1995
BUCHALTER FAUSER FEMORAL COMPONENTS
K952686
Biomet, Inc.
Orthopedic · 99d
Cleared Aug 08, 1995
STELKAST ALL POLYETHYLENE ACETABULAR CUP
K953169
Stelkast Company
Orthopedic · 32d
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 Mar 20, 1995
HOWMEDICA(R) 28MM ZIRCONIA FEMORAL HEADS
K946026
Howmedica, Inc.
Orthopedic · 98d
Cleared Mar 06, 1995
OSTEONICS RESTORATION MONOLITHIC HIP STEM
K943774
Osteonics Corp.
Orthopedic · 216d
Cleared Feb 14, 1995
NATURAL-HIP(TM) SYSTEM - CALCAR REPLCEMENT STEM
K945516
Intermedics Orthopedics
Orthopedic · 97d
Cleared Jan 19, 1995
SENTRY TOTAL HIP
K945089
Howmedica Corp.
Orthopedic · 94d