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 Howmedica Osteonics Corp..

534
Total
534
Cleared
144d
Avg days
1985
Since
534 devices
337–360 of 534
Cleared Dec 13, 2001
ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTS
K013935
Sulzer Orthopedics, Inc.
Orthopedic · 15d
Cleared Nov 27, 2001
APEX MODULAR ALUMINA FEMORAL HEAD
K012918
Apex Surgical, LLC
Orthopedic · 89d
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
APEX MODULAR ZIRCONIA FEMORAL HEAD
K003923
Apex Surgical, LLC
Orthopedic · 90d
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
Cleared Apr 24, 2000
RESPONSE 2000 CEMENTED HIP STEM
K000432
DePuy Orthopaedics, Inc.
Orthopedic · 75d
Cleared Feb 18, 2000
MRS-TITAN
K992359
Rotec Medizintechnik GmbH
Orthopedic · 219d
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 Jan 21, 2000
MRP-TITAN
K992403
Rotec Medizintechnik GmbH
Orthopedic · 186d
Cleared Dec 02, 1999
MS-30 FEMORAL STEM
K993043
Sulzer Orthopedics, Inc.
Orthopedic · 83d