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
145–168 of 529
Cleared Jul 19, 2012
SL-PLUS STANDARD AND LATERAL FEMORAL STEM WITH TI/HA COATING
K120211
Smith & Nephew, Inc.
Orthopedic · 177d
Cleared Apr 11, 2011
TAPER OXINIUM FEMORAL HEAD
K110101
Smith & Nephew, Inc.
Orthopedic · 88d
Cleared Mar 10, 2011
DEPUY CORAIL HIP SYSTEM, REVISION STEM
K093736
DePuy Orthopaedics, Inc.
Orthopedic · 461d
Cleared Feb 03, 2011
MODULAR DUAL MOBILITY LINER, X3 ACETABULAR INSERT
K103233
Howmedica Osteonics Corp.
Orthopedic · 93d
Cleared Jul 30, 2010
ZIMMER SEGMENTAL SYSTEM PROXIMAL FEMORAL COMPONENT AND SMALL DIAMETER STEM EXTENSIONS
K101296
Zimmer, Inc.
Orthopedic · 81d
Cleared May 05, 2010
BIOLOX DELTA CERAMIC FEMORAL HEADS
K100412
Smith & Nephew, Inc.
Orthopedic · 78d
Cleared Apr 28, 2010
PROFEMUR HIP SYSTEM MODULAR NECKS
K100866
Wrightmedicaltechnologyinc
Orthopedic · 30d
Cleared Apr 15, 2010
SLR-PLUS STANDARD AND LATERAL FEMORAL STEMS
K093991
Smith & Nephew, Inc.
Orthopedic · 112d
Cleared Feb 04, 2010
LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS
K093846
Zimmer, Inc.
Orthopedic · 51d
Cleared Mar 11, 2009
BIOLOX DELTA CERAMIC FEMORAL HEADS
K083762
Smith & Nephew, Inc.
Orthopedic · 83d
Cleared Feb 09, 2009
SMITH & NEPHEW SL-PLUS MIA STANDARD AND LATERAL FEMORAL HIP STEM
K082371
Smith & Nephew, Inc.
Orthopedic · 175d
Cleared Jan 15, 2009
BIOLOX DELTA OPTION CERAMIC HEADS
K082996
Biomet, Inc.
Orthopedic · 99d
Cleared Sep 26, 2008
ZIMMER SEGMENTAL SYSTEM VARIABLE STIFFNESS STEM EXTENSIONS AND INTERCALARY SEGMENTS
K081860
Zimmer, Inc.
Orthopedic · 87d
Cleared Jun 09, 2008
SL-PLUS STANDARD AND LATERAL HIP STEMS
K072852
Smith & Nephew, Inc.
Orthopedic · 249d
Cleared Feb 21, 2008
DEPUY TRI-LOCK BONE PRESERVATION STEM
K073570
DePuy Orthopaedics, Inc.
Orthopedic · 63d
Cleared Feb 06, 2008
DYNASTY CERAMIC FEMORAL HEAD
K072656
Wrightmedicaltechnologyinc
Orthopedic · 139d
Cleared Nov 19, 2007
BIOLOX DELTA CERAMIC FEMORAL HEAD
K071535
Zimmer, Inc.
Orthopedic · 167d
Cleared Sep 28, 2007
DEPUY DELTA TS CERAMIC FEMORAL HEADS
K071830
DePuy Orthopaedics, Inc.
Orthopedic · 87d
Cleared Sep 13, 2007
STRYKER MODULAR HIP SYSTEM
K071082
Howmedica Osteonics Corp.
Orthopedic · 149d
Cleared Sep 11, 2007
DEPUY CORAIL AMT DYSPLASIA HIP PROSTHESIS
K070554
DePuy Orthopaedics, Inc.
Orthopedic · 196d
Cleared May 16, 2007
UNIVERSAL TAPER DELTA FEMORAL HEAD
K070885
Howmedica Osteonics Corp.
Orthopedic · 47d
Cleared Dec 20, 2006
TRIDENT II ACETABULAR SYSTEM
K063616
Howmedica Osteonics Corp.
Orthopedic · 15d
Cleared Nov 30, 2006
MODIFICATION: TO DEPUY DELTA CERAMIC FEMORAL HEAD
K062748
DePuy Orthopaedics, Inc.
Orthopedic · 77d
Cleared Nov 22, 2006
EXCIA TOTAL HIP SYSTEM 36MM CERAMIC HEAD
K062684
Aesculap, Inc.
Orthopedic · 75d