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..

531
Total
531
Cleared
144d
Avg days
1985
Since
531 devices
289–312 of 531
Cleared Sep 06, 2005
SC CERAMIC BALL HEADS
K052237
Orthopedic Alliance, LLC
Orthopedic · 20d
Cleared Jul 19, 2005
EXACTECH 12/14 ALUMINA FEMORAL HEADS 36 MM
K051682
Exactech, Inc.
Orthopedic · 26d
Cleared Jul 19, 2005
MODIFICATION TO V-40/C-TAPER ADAPTER SLEEVE
K051737
Howmedica Osteonics Corp.
Orthopedic · 21d
Cleared Jul 19, 2005
SECUR-FIT MAX AND PLUS MAX HIP STEMS
K051738
Howmedica Osteonics Corp.
Orthopedic · 21d
Cleared Jul 12, 2005
BIOLOX DELTA CERAMIC FEMORAL HEADS
K051588
Howmedica Osteonics Corp.
Orthopedic · 27d
Cleared Jun 29, 2005
ARCOMXL POLYETHYLENE LINERS AND BIOLOX DELTA HEADS
K051411
Biomet, Inc.
Orthopedic · 29d
Cleared May 11, 2005
ALUMINA HEAD
K050556
Fournitures Hospitalieres Industrie
Orthopedic · 69d
Cleared Apr 18, 2005
WAGNER SL REVISION STEM LATERAL
K043356
Zimmer Austin, Inc.
Orthopedic · 133d
Cleared Mar 25, 2005
BIOLOX DELTA CERAMIC HEADS
K042091
Biomet, Inc.
Orthopedic · 234d
Cleared Feb 11, 2005
HOWMEDICA OSTEONICS ZIRCONIA-TOUGHENED-ALUMINA (BIOLOX DELTA) CERAMIC FEMORAL HEADS
K041940
Howmedica Osteonics Corp.
Orthopedic · 207d
Cleared Feb 11, 2005
CORAIL AMT HIP PROSTHESIS
K042992
DePuy Orthopaedics, Inc.
Orthopedic · 102d
Cleared Nov 17, 2004
ALUMINA HEAD
K042035
Fournitures Hospitalieres Industrie
Orthopedic · 111d
Cleared Nov 16, 2004
OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM
K041443
Osteoimplant Technology, Inc.
Orthopedic · 168d
Cleared Nov 09, 2004
SECUR-FIT HA AND SECUR-FIT PLUS HIP STEMS
K041170
Howmedica Osteonics Corp.
Orthopedic · 189d
Cleared Nov 09, 2004
NOVATION 12/14 PRESS-FIT FEMORAL STEM
K042842
Exactech, Inc.
Orthopedic · 26d
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 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 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