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 Smith & Nephew, Inc., Howmedica Osteonics Corp. and Medacta International S.A..

529
Total
529
Cleared
144d
Avg days
1985
Since
529 devices
193–216 of 529
Cleared Dec 19, 2001
ZIRCONIA CERAMIC FEMORAL HEAD - 12/14 TAPER
K013989
Smith & Nephew, Inc.
Orthopedic · 15d
Cleared Oct 03, 2001
PRO-FEMUR
K012091
Wrightmedicaltechnologyinc
Orthopedic · 90d
Cleared Mar 20, 2001
PORTRAIT FEMORAL COMPONENT
K010560
Biomet, Inc.
Orthopedic · 22d
Cleared Nov 30, 2000
V-40/C-TAPER ADAPTER SLEEVE
K003379
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Nov 28, 2000
OSTEONICS ALUMINA C-TAPER HEAD
K003391
Howmedica Osteonics Corp.
Orthopedic · 28d
Cleared Nov 24, 2000
ALUMINA V40 HEAD
K003413
Howmedica Osteonics Corp.
Orthopedic · 22d
Cleared Sep 14, 2000
ACCOLADE C FEMORAL COMPONENT
K002320
Howmedica Osteonics Corp.
Orthopedic · 45d
Cleared Aug 04, 2000
TRIDENT ACETABULAR SHELLS: PS
K001449
Howmedica Osteonics Corp.
Orthopedic · 87d
Cleared Feb 15, 2000
PLR SPLINED REVISION STEM
K994184
Biomet, Inc.
Orthopedic · 67d
Cleared Feb 11, 2000
EXETER CERAMIC FEMORAL HEADS
K993889
Howmedica Osteonics Corp.
Orthopedic · 87d
Cleared Jan 28, 2000
BIOLOX ALUMINA CERAMIC FEMORAL HEAD
K991162
Smith & Nephew, Inc.
Orthopedic · 296d
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 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 May 29, 1998
OSTEOLOCK ACETABULAR CUP
K981201
Howmedica Corp.
Orthopedic · 57d
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 Aug 11, 1997
ZIRCONIA CERAMIC MODULAR HEADS (NORTON ADVANCED CERAMICS)
K964431
Biomet, Inc.
Orthopedic · 279d
Cleared Jul 30, 1997
ZIRCONIA CERAMIC FEMORAL HEAD (12/14 TAPER)
K971752
Zimmer, Inc.
Orthopedic · 79d
Cleared Apr 09, 1997
RELIANCE PF FEMORAL STEMS
K970200
Howmedica Corp.
Orthopedic · 78d
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 Oct 08, 1996
ZIMMER ZIRCONIA CERAMIC FEMORAL HEAD
K955877
Zimmer, Inc.
Orthopedic · 287d