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
Cleared
Jul 14, 2006
SYNERGY HIP SYSTEM
Smith & Nephew, Inc.
General & Plastic Surgery
88d
Cleared
Jul 12, 2006
PATIENT MATCHED HIP STEM
Smith & Nephew, Inc.
Orthopedic
233d
Cleared
Jun 06, 2006
36MM BIOLOX DELTA CERAMIC HEADS
Biomet, Inc.
Orthopedic
27d
Cleared
May 26, 2006
EXCIA TOTAL HIP SYSTEM 12/14 TRUNNION WITH CERAMIC HEAD
Aesculap, Inc.
Orthopedic
52d
Cleared
Dec 07, 2005
SMITH & NEPHEW PLATFORM HIP STEM
Smith & Nephew, Inc.
Orthopedic
107d
Cleared
Oct 27, 2005
V40 BIOLOX DELTA CERAMIC FEMORAL HEADS
Howmedica Osteonics Corp.
Orthopedic
28d
Cleared
Jul 19, 2005
MODIFICATION TO V-40/C-TAPER ADAPTER SLEEVE
Howmedica Osteonics Corp.
Orthopedic
21d
Cleared
Jul 19, 2005
SECUR-FIT MAX AND PLUS MAX HIP STEMS
Howmedica Osteonics Corp.
Orthopedic
21d
Cleared
Jul 12, 2005
BIOLOX DELTA CERAMIC FEMORAL HEADS
Howmedica Osteonics Corp.
Orthopedic
27d
Cleared
Jun 29, 2005
ARCOMXL POLYETHYLENE LINERS AND BIOLOX DELTA HEADS
Biomet, Inc.
Orthopedic
29d
Cleared
Mar 25, 2005
BIOLOX DELTA CERAMIC HEADS
Biomet, Inc.
Orthopedic
234d
Cleared
Feb 11, 2005
HOWMEDICA OSTEONICS ZIRCONIA-TOUGHENED-ALUMINA (BIOLOX DELTA) CERAMIC FEMORAL HEADS
Howmedica Osteonics Corp.
Orthopedic
207d
Cleared
Feb 11, 2005
CORAIL AMT HIP PROSTHESIS
DePuy Orthopaedics, Inc.
Orthopedic
102d
Cleared
Nov 09, 2004
SECUR-FIT HA AND SECUR-FIT PLUS HIP STEMS
Howmedica Osteonics Corp.
Orthopedic
189d
Cleared
Aug 25, 2004
MODIFICATION TO RESTORATION MODULAR SYSTEM
Howmedica Osteonics Corp.
Orthopedic
156d
Cleared
Apr 29, 2004
MS-30 FEMORAL STEM STANDARD AND LATERAL
Zimmer, Inc.
Orthopedic
31d
Cleared
Apr 08, 2004
MODIFICATION TO DEPUY CERAMIC FEMORAL HEAD
DePuy Orthopaedics, Inc.
Orthopedic
28d
Cleared
Jun 03, 2003
ALUMINA CERAMIC FEMORAL HEADS, 28 AND 32 MM
Zimmer, Inc.
Orthopedic
88d
Cleared
Jan 28, 2003
ALUMINA V40 FEMORAL HEADS
Howmedica Osteonics Corp.
Orthopedic
67d
Cleared
Oct 17, 2002
GMRS PRESS FIT STEMS WITH PUREFIX HA
Howmedica Osteonics Corp.
Orthopedic
86d
Cleared
Sep 23, 2002
RESTORATION MODULAR SYSTEM
Howmedica Osteonics Corp.
Orthopedic
53d
Cleared
Aug 26, 2002
ACCOLADE C FEMORAL STEMS
Howmedica Osteonics Corp.
Orthopedic
24d
Cleared
Jun 11, 2002
TOTAL HIP FEMORAL HEAD - 12/14 TAPER
Smith & Nephew, Inc.
Orthopedic
21d
Cleared
Apr 03, 2002
2 PIECE MODULAR HIP STEM
Howmedica Osteonics Corp.
Orthopedic
198d