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
241–264 of 531
Cleared Jun 06, 2006
36MM BIOLOX DELTA CERAMIC HEADS
K061312
Biomet, Inc.
Orthopedic · 27d
Cleared May 26, 2006
EXCIA TOTAL HIP SYSTEM 12/14 TRUNNION WITH CERAMIC HEAD
K060918
Aesculap, Inc.
Orthopedic · 52d
Cleared Apr 28, 2006
ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS
K060577
Ortho Development Corp.
Orthopedic · 53d
Cleared Mar 17, 2006
ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS WITH PRES-FIT STEMS
K053587
Ortho Development Corp.
Orthopedic · 84d
Cleared Feb 06, 2006
MODIFICATION TO: EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS
K060107
Exactech, Inc.
Orthopedic · 24d
Cleared Dec 27, 2005
ACUMATCH 12/14 C-SERIES CEMENTED FEMORAL STEMS (SIZE 1-6), ACUMATCH 12/14 L-SERIES CEMENTED FEMORAL STEMS (SIZE 1-5)
K052787
Exactech, Inc.
Orthopedic · 85d
Cleared Dec 07, 2005
SMITH & NEPHEW PLATFORM HIP STEM
K052275
Smith & Nephew, Inc.
Orthopedic · 107d
Cleared Dec 01, 2005
ACUMATCH M-SERIES LPB 12/14 FEMORAL STEM
K051858
Exactech, Inc.
Orthopedic · 146d
Cleared Nov 18, 2005
EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS
K050398
Exactech, Inc.
Orthopedic · 275d
Cleared Oct 27, 2005
V40 BIOLOX DELTA CERAMIC FEMORAL HEADS
K052718
Howmedica Osteonics Corp.
Orthopedic · 28d
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 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 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 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