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
Jan 27, 1997
PATIENT SPECIFIC IMPLANT (PSI) HIP FEMORAL COMPONENT
Hayes Medical, Inc.
Orthopedic
84d
Cleared
Jan 24, 1997
DEPUY/ACE MODIFIED MEDICAL ASPECT (MMA) FRACTURE STEM
Depuy, Inc.
Orthopedic
60d
Cleared
Jan 14, 1997
BRIDGE LONG STEM FEMORAL COMPONENT
Wrightmedicaltechnologyinc
Orthopedic
82d
Cleared
Dec 27, 1996
CORAIL
Landos, Inc.
Orthopedic
543d
Cleared
Dec 27, 1996
WHITESIDE BIOMECHANICS ZIRCONIA CERAMIC FEMORAL HEAD
Whiteside Biomechanics, Inc.
Orthopedic
72d
Cleared
Oct 08, 1996
ZIMMER ZIRCONIA CERAMIC FEMORAL HEAD
Zimmer, Inc.
Orthopedic
287d
Cleared
Aug 29, 1996
P.F.C. CERAMIC HIP HEAD
Johnson & Johnson Professionals, Inc.
Orthopedic
79d
Cleared
Aug 19, 1996
ZWEYMUELLER SL FEMORAL HIP STEM
Intermedics Orthopedics
Orthopedic
81d
Cleared
Aug 05, 1996
WAGNER REVISION STEM
Intermedics Orthopedics
Orthopedic
175d
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 20, 1996
CONSENSUS ZIRCONIA FEMORAL HEAD
U.S. Medical Products, Inc.
Orthopedic
90d
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
Jan 18, 1996
BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD
Biologically Oriented Prostheses
Orthopedic
93d
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
Nov 06, 1995
CONSENSUS ZIRCONIA HEAD SIZE -3.5, 0, +5
U.S. Medical Products, Inc.
Orthopedic
84d
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