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
289–312 of 531
Cleared Aug 04, 2000
TRIDENT ACETABULAR SHELLS: PS
K001449
Howmedica Osteonics Corp.
Orthopedic · 87d
Cleared Jun 05, 2000
BOFOR REVISION COUP
K993874
Plus Orthopedics
Orthopedic · 203d
Cleared Apr 24, 2000
RESPONSE 2000 HIP STEM
K000392
DePuy Orthopaedics, Inc.
Orthopedic · 77d
Cleared Apr 24, 2000
RESPONSE 2000 CEMENTED HIP STEM
K000432
DePuy Orthopaedics, Inc.
Orthopedic · 75d
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 Dec 02, 1999
MS-30 FEMORAL STEM
K993043
Sulzer Orthopedics, Inc.
Orthopedic · 83d
Cleared Nov 23, 1999
ZYRANOX ZIRCONIA CERAMIC FEMORAL HEADS
K992235
Corin USA
Orthopedic · 144d
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 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