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 19, 2012
SL-PLUS STANDARD AND LATERAL FEMORAL STEM WITH TI/HA COATING
Smith & Nephew, Inc.
Orthopedic
177d
Cleared
Apr 11, 2011
TAPER OXINIUM FEMORAL HEAD
Smith & Nephew, Inc.
Orthopedic
88d
Cleared
Mar 10, 2011
DEPUY CORAIL HIP SYSTEM, REVISION STEM
DePuy Orthopaedics, Inc.
Orthopedic
461d
Cleared
Feb 03, 2011
MODULAR DUAL MOBILITY LINER, X3 ACETABULAR INSERT
Howmedica Osteonics Corp.
Orthopedic
93d
Cleared
Jul 30, 2010
ZIMMER SEGMENTAL SYSTEM PROXIMAL FEMORAL COMPONENT AND SMALL DIAMETER STEM EXTENSIONS
Zimmer, Inc.
Orthopedic
81d
Cleared
May 05, 2010
BIOLOX DELTA CERAMIC FEMORAL HEADS
Smith & Nephew, Inc.
Orthopedic
78d
Cleared
Apr 28, 2010
PROFEMUR HIP SYSTEM MODULAR NECKS
Wrightmedicaltechnologyinc
Orthopedic
30d
Cleared
Apr 15, 2010
SLR-PLUS STANDARD AND LATERAL FEMORAL STEMS
Smith & Nephew, Inc.
Orthopedic
112d
Cleared
Feb 04, 2010
LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS
Zimmer, Inc.
Orthopedic
51d
Cleared
Mar 11, 2009
BIOLOX DELTA CERAMIC FEMORAL HEADS
Smith & Nephew, Inc.
Orthopedic
83d
Cleared
Feb 09, 2009
SMITH & NEPHEW SL-PLUS MIA STANDARD AND LATERAL FEMORAL HIP STEM
Smith & Nephew, Inc.
Orthopedic
175d
Cleared
Jan 15, 2009
BIOLOX DELTA OPTION CERAMIC HEADS
Biomet, Inc.
Orthopedic
99d
Cleared
Sep 26, 2008
ZIMMER SEGMENTAL SYSTEM VARIABLE STIFFNESS STEM EXTENSIONS AND INTERCALARY SEGMENTS
Zimmer, Inc.
Orthopedic
87d
Cleared
Jun 09, 2008
SL-PLUS STANDARD AND LATERAL HIP STEMS
Smith & Nephew, Inc.
Orthopedic
249d
Cleared
Feb 21, 2008
DEPUY TRI-LOCK BONE PRESERVATION STEM
DePuy Orthopaedics, Inc.
Orthopedic
63d
Cleared
Feb 06, 2008
DYNASTY CERAMIC FEMORAL HEAD
Wrightmedicaltechnologyinc
Orthopedic
139d
Cleared
Nov 19, 2007
BIOLOX DELTA CERAMIC FEMORAL HEAD
Zimmer, Inc.
Orthopedic
167d
Cleared
Sep 28, 2007
DEPUY DELTA TS CERAMIC FEMORAL HEADS
DePuy Orthopaedics, Inc.
Orthopedic
87d
Cleared
Sep 13, 2007
STRYKER MODULAR HIP SYSTEM
Howmedica Osteonics Corp.
Orthopedic
149d
Cleared
Sep 11, 2007
DEPUY CORAIL AMT DYSPLASIA HIP PROSTHESIS
DePuy Orthopaedics, Inc.
Orthopedic
196d
Cleared
May 16, 2007
UNIVERSAL TAPER DELTA FEMORAL HEAD
Howmedica Osteonics Corp.
Orthopedic
47d
Cleared
Dec 20, 2006
TRIDENT II ACETABULAR SYSTEM
Howmedica Osteonics Corp.
Orthopedic
15d
Cleared
Nov 30, 2006
MODIFICATION: TO DEPUY DELTA CERAMIC FEMORAL HEAD
DePuy Orthopaedics, Inc.
Orthopedic
77d
Cleared
Nov 22, 2006
EXCIA TOTAL HIP SYSTEM 36MM CERAMIC HEAD
Aesculap, Inc.
Orthopedic
75d