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
385–408 of 531
Cleared Jan 27, 1997
PATIENT SPECIFIC IMPLANT (PSI) HIP FEMORAL COMPONENT
K964395
Hayes Medical, Inc.
Orthopedic · 84d
Cleared Jan 24, 1997
DEPUY/ACE MODIFIED MEDICAL ASPECT (MMA) FRACTURE STEM
K964704
Depuy, Inc.
Orthopedic · 60d
Cleared Jan 14, 1997
BRIDGE LONG STEM FEMORAL COMPONENT
K964249
Wrightmedicaltechnologyinc
Orthopedic · 82d
Cleared Dec 27, 1996
CORAIL
K953111
Landos, Inc.
Orthopedic · 543d
Cleared Dec 27, 1996
WHITESIDE BIOMECHANICS ZIRCONIA CERAMIC FEMORAL HEAD
K964150
Whiteside Biomechanics, Inc.
Orthopedic · 72d
Cleared Oct 08, 1996
ZIMMER ZIRCONIA CERAMIC FEMORAL HEAD
K955877
Zimmer, Inc.
Orthopedic · 287d
Cleared Aug 29, 1996
P.F.C. CERAMIC HIP HEAD
K962248
Johnson & Johnson Professionals, Inc.
Orthopedic · 79d
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 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