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
313–336 of 531
Cleared Oct 17, 2002
GMRS PRESS FIT STEMS WITH PUREFIX HA
K022403
Howmedica Osteonics Corp.
Orthopedic · 86d
Cleared Sep 23, 2002
RESTORATION MODULAR SYSTEM
K022549
Howmedica Osteonics Corp.
Orthopedic · 53d
Cleared Aug 26, 2002
ACCOLADE C FEMORAL STEMS
K022555
Howmedica Osteonics Corp.
Orthopedic · 24d
Cleared Jul 24, 2002
MPF ACETABULAR CUP GENERATION 2
K022120
Plus Orthopedics
Orthopedic · 23d
Cleared Jun 11, 2002
TOTAL HIP FEMORAL HEAD - 12/14 TAPER
K021673
Smith & Nephew, Inc.
Orthopedic · 21d
Cleared May 14, 2002
MS-30 LATERAL FEMORAL STEM
K020713
Sulzer Orthopedics, Inc.
Orthopedic · 70d
Cleared Apr 03, 2002
2 PIECE MODULAR HIP STEM
K013106
Howmedica Osteonics Corp.
Orthopedic · 198d
Cleared Jan 28, 2002
DEPUY FEMORAL HEADS
K011533
DePuy Orthopaedics, Inc.
Orthopedic · 255d
Cleared Dec 19, 2001
ZIRCONIA CERAMIC FEMORAL HEAD - 12/14 TAPER
K013989
Smith & Nephew, Inc.
Orthopedic · 15d
Cleared Dec 13, 2001
ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTS
K013935
Sulzer Orthopedics, Inc.
Orthopedic · 15d
Cleared Oct 03, 2001
PRO-FEMUR
K012091
Wrightmedicaltechnologyinc
Orthopedic · 90d
Cleared Sep 07, 2001
MPF ACETABULAR CUP
K011836
Plus Orthopedics
Orthopedic · 87d
Cleared Apr 18, 2001
CLS VARUS STEM/CLS 135 STEM
K010839
Sulzer Orthopedics, Inc.
Orthopedic · 28d
Cleared Apr 06, 2001
LPC-PLUS ACETABULAR CUP
K003274
Plus Orthopedics
Orthopedic · 170d
Cleared Mar 20, 2001
PORTRAIT FEMORAL COMPONENT
K010560
Biomet, Inc.
Orthopedic · 22d
Cleared Jan 19, 2001
OTI CERAMIC FEMORAL HEAD SYSTEM
K003316
Osteoimplant Technology, Inc.
Orthopedic · 88d
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 Sep 01, 2000
FENNING HIP STEM
K002441
DePuy Orthopaedics, Inc.
Orthopedic · 23d
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