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
337–360 of 531
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 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 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 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 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
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
P.C.A. E-SERIES HIP- CEMENTLESS USE
K945093
Howmedica, Inc.
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