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
313–336 of 534
Cleared Sep 15, 2004
CLS SPOTORNO STEM
K042249
Zimmer Austin, Inc.
Orthopedic · 27d
Cleared Aug 25, 2004
MODIFICATION TO RESTORATION MODULAR SYSTEM
K040734
Howmedica Osteonics Corp.
Orthopedic · 156d
Cleared Apr 29, 2004
MS-30 FEMORAL STEM STANDARD AND LATERAL
K040803
Zimmer, Inc.
Orthopedic · 31d
Cleared Apr 08, 2004
MODIFICATION TO DEPUY CERAMIC FEMORAL HEAD
K040644
DePuy Orthopaedics, Inc.
Orthopedic · 28d
Cleared Mar 12, 2004
STELKAST 32MM MODULAR CERAMIC FEMORAL HEAD
K033944
Stelkast Company
Orthopedic · 84d
Cleared Dec 17, 2003
MODIFICATION TO ALLOCLASSIC ZWEYMULLER SL OFFSET FEMORAL STEM
K033664
Centerpulse Orthopedics, Inc.
Orthopedic · 26d
Cleared Oct 24, 2003
CONVERGE RETI-LOCK MULTI-HOLE REINFORCEMENT CUP
K032348
Centerpulse Orthopedics, Inc.
Orthopedic · 86d
Cleared Sep 22, 2003
WAGNER CONE PROSTHESIS
K032380
Centerpulse Orthopedics, Inc.
Orthopedic · 52d
Cleared Jul 01, 2003
DEPUY CERAMIC FEMORAL HEADS
K031803
DePuy Orthopaedics, Inc.
Orthopedic · 20d
Cleared Jun 03, 2003
ALUMINA CERAMIC FEMORAL HEADS, 28 AND 32 MM
K030724
Zimmer, Inc.
Orthopedic · 88d
Cleared May 23, 2003
GMRS PRESS FIT STEMS WITH PUREFIX HA
K031217
Howmedica Osteonics
Orthopedic · 36d
Cleared Apr 10, 2003
CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM
K030151
Hayes Medical, Inc.
Orthopedic · 85d
Cleared Mar 06, 2003
ALLOCLASSIC ZWEYMUELLER SL/SLL FEMORAL STEM
K030373
Centerpulse Orthopedics, Inc.
Orthopedic · 30d
Cleared Jan 28, 2003
ALUMINA V40 FEMORAL HEADS
K023901
Howmedica Osteonics Corp.
Orthopedic · 67d
Cleared Dec 05, 2002
ASCENDENT ACETABULAR SYSTEM
K022985
Sulzer Orthopedics, Inc.
Orthopedic · 87d
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