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
Cleared
Aug 05, 1996
APR OVERSIZED HIP STEM
Intermedics Orthopedics
Orthopedic
80d
Cleared
Jul 19, 1996
NATURAL-HIP SYSTEM - CALCAR REPLACEMENT HIP STEM
Intermedics Orthopedics
Orthopedic
77d
Cleared
Jul 09, 1996
APR FULLY TEXTURED HIP STEM
Intermedics Orthopedics
Orthopedic
76d
Cleared
Jun 07, 1996
CLS STEM (MODIFICATION)
Intermedics Orthopedics
Orthopedic
312d
Cleared
Apr 05, 1996
IMPLEX CERAMIC HEAD
Implex Corp.
Orthopedic
148d
Cleared
Feb 16, 1996
BIMETRIC COCR HEAD/NECK REPLACEMENT HIP STEM
Biomet, Inc.
Orthopedic
87d
Cleared
Jan 31, 1996
FINE GRAIN CAST COBALT CHROMIUM HIP STEMS
Biomet, Inc.
Orthopedic
166d
Cleared
Nov 29, 1995
CLS ACETABULAR COMPONENT (MODIFICATION)
Intermedics Orthopedics
Orthopedic
121d
Cleared
Nov 29, 1995
WAGNER REVISION STEM (MODIFICATION)
Intermedics Orthopedics
Orthopedic
121d
Cleared
Oct 20, 1995
ZIRCONIA CERAMIC FEMORAL HEAD
Wrightmedicaltechnologyinc
Orthopedic
393d
Cleared
Sep 19, 1995
BUCHALTER FAUSER FEMORAL COMPONENTS
Biomet, Inc.
Orthopedic
99d
Cleared
Aug 08, 1995
STELKAST ALL POLYETHYLENE ACETABULAR CUP
Stelkast Company
Orthopedic
32d
Cleared
Jul 03, 1995
V40 ZIRCONIA FEMORAL HEADS
Howmedica Corp.
Orthopedic
41d
Cleared
Jun 30, 1995
ZIRCONIA ARTICUL/EZE FEMORAL BALLS
Depuy, Inc.
Orthopedic
58d
Cleared
Mar 20, 1995
HOWMEDICA(R) 28MM ZIRCONIA FEMORAL HEADS
Howmedica, Inc.
Orthopedic
98d
Cleared
Mar 06, 1995
OSTEONICS RESTORATION MONOLITHIC HIP STEM
Osteonics Corp.
Orthopedic
216d
Cleared
Feb 14, 1995
NATURAL-HIP(TM) SYSTEM - CALCAR REPLCEMENT STEM
Intermedics Orthopedics
Orthopedic
97d
Cleared
Jan 19, 1995
SENTRY TOTAL HIP
Howmedica Corp.
Orthopedic
94d
Cleared
Jan 19, 1995
HOWMEDICA ZIRCONIA CERAMIC FEMORAL HEAD
Howmedica Corp.
Orthopedic
94d
Cleared
Jan 19, 1995
P.C.A.PRIMARY HIP- CEMENTLESS USE
Howmedica Corp.
Orthopedic
94d
Cleared
Jan 19, 1995
P.C.A. E-SERIES HIP- CEMENTLESS USE
Howmedica, Inc.
Orthopedic
94d
Cleared
Jan 19, 1995
HNR-PC HIP
Howmedica Corp.
Orthopedic
94d
Cleared
Jan 19, 1995
APC FEMORAL COMPONENT
Howmedica Corp.
Orthopedic
94d
Cleared
Jan 19, 1995
CDH HIP STEM
Howmedica Corp.
Orthopedic
94d