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 Smith & Nephew, Inc., Howmedica Osteonics Corp. and Medacta International S.A..

529
Total
529
Cleared
144d
Avg days
1985
Since
529 devices
169–192 of 529
Cleared Jul 14, 2006
SYNERGY HIP SYSTEM
K061066
Smith & Nephew, Inc.
General & Plastic Surgery · 88d
Cleared Jul 12, 2006
PATIENT MATCHED HIP STEM
K053246
Smith & Nephew, Inc.
Orthopedic · 233d
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 Dec 07, 2005
SMITH & NEPHEW PLATFORM HIP STEM
K052275
Smith & Nephew, Inc.
Orthopedic · 107d
Cleared Oct 27, 2005
V40 BIOLOX DELTA CERAMIC FEMORAL HEADS
K052718
Howmedica Osteonics Corp.
Orthopedic · 28d
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 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 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 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 Jun 11, 2002
TOTAL HIP FEMORAL HEAD - 12/14 TAPER
K021673
Smith & Nephew, Inc.
Orthopedic · 21d
Cleared Apr 03, 2002
2 PIECE MODULAR HIP STEM
K013106
Howmedica Osteonics Corp.
Orthopedic · 198d