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..

534
Total
534
Cleared
144d
Avg days
1985
Since
534 devices
361–384 of 534
Cleared Nov 23, 1999
ZYRANOX ZIRCONIA CERAMIC FEMORAL HEADS
K992235
Corin USA
Orthopedic · 144d
Cleared Sep 22, 1999
BIOPRO RIMMED ACETABULAR COMPOMENT
K992144
Biologically Oriented Prostheses
Orthopedic · 90d
Cleared Aug 27, 1999
PLUS CERAMIC HEAD PROSTHESES (ALUMINA AND ZIRKONIA)
K990261
Plus Orthopedics
Orthopedic · 212d
Cleared Jul 30, 1999
ZIRCONIA 22.22MM CERAMIC MODULAR HEADS
K991708
Biomet, Inc.
Orthopedic · 72d
Cleared Jun 29, 1999
OSTEONICS ALUMINA C-TAPER HEAD, OSTEONICS TRIDENT POLYETHYLENE INSERTS
K991952
Howmedica Osteonics Corp.
Orthopedic · 19d
Cleared Jun 11, 1999
IMPLEX ALUMINA FEMORAL HEAD
K990183
Implex Corp.
Orthopedic · 142d
Cleared Jun 01, 1999
FOUNDATION POROUS HIP STEM
K991226
Encore Orthopedics, Inc.
Orthopedic · 50d
Cleared Dec 22, 1998
TYPE 3 FEMORAL COMPONENTS
K983404
Howmedica Corp.
Orthopedic · 85d
Cleared Jul 17, 1998
BIOLOX ALUMINA CERAMIC FEMORAL HEAD
K981847
Smith & Nephew, Inc.
Orthopedic · 52d
Cleared Jun 25, 1998
SMC 28MM CERAMIC FEMORAL HEADS
K981302
Signal Medical Corp.
Orthopedic · 77d
Cleared May 29, 1998
OSTEOLOCK ACETABULAR CUP
K981201
Howmedica Corp.
Orthopedic · 57d
Cleared Apr 29, 1998
OSTEONICS GAP-II RESTORATION ACETABULAR SHELLS
K980774
Osteonics Corp.
Orthopedic · 58d
Cleared Apr 16, 1998
PARTNERSHIP CALCAR FEMORAL COMPONENTS
K980239
Howmedica, Inc.
Orthopedic · 83d
Cleared Apr 16, 1998
PRESS-FIT STEM
K980473
Encore Orthopedics, Inc.
Orthopedic · 69d
Cleared Apr 09, 1998
S-ROM ZIRCONIA CERAMIC FEMORAL HIP HEAD
K980081
Johnson & Johnson Professionals, Inc.
Orthopedic · 90d
Cleared Jan 06, 1998
CLS STEM, WAGNER REVISION STEM, ALLOCLASSIC ZWEYMULLER STEM, SL
K973837
Sulzer Orthopedics, Inc.
Orthopedic · 90d
Cleared Dec 19, 1997
NATURAL-HIP COCR OFFSET STEM
K973681
Sulzer Orthopedics, Inc.
Orthopedic · 84d
Cleared Dec 05, 1997
MERIDIAN TITANIUM FEMORAL STEMS
K972228
Howmedica, Inc.
Orthopedic · 175d
Cleared Nov 24, 1997
WHITESIDE BIOMECHANICS, INC. CERAMIC UNIPOLAR FEMORAL HEAD
K973261
Whiteside Biomechanics, Inc.
Orthopedic · 87d
Cleared Nov 20, 1997
S-ROM ZIRCONIA CERAMIC FEMORAL HIP HEAD
K973307
Johnson & Johnson Professionals, Inc.
Orthopedic · 78d
Cleared Nov 14, 1997
MOST HEX INTRAMEDULLARY (I/M) STEM
K973087
Sulzer Orthopedics, Inc.
Orthopedic · 88d
Cleared Nov 03, 1997
PARTNERSHIP REVISION FEMORAL STEMS
K972893
Howmedica Corp.
Orthopedic · 90d
Cleared Oct 15, 1997
ZIRCONIA CERAMIC FEMORAL HEAD
K972690
Zimmer, Inc.
Orthopedic · 90d
Cleared Oct 01, 1997
PRECEDENT REVISION HIP SYSTEM
K972637
Sulzer Orthopedics, Inc.
Orthopedic · 78d