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..

534
Total
534
Cleared
144d
Avg days
1985
Since
534 devices
265–288 of 534
Cleared Feb 21, 2008
DEPUY TRI-LOCK BONE PRESERVATION STEM
K073570
DePuy Orthopaedics, Inc.
Orthopedic · 63d
Cleared Feb 13, 2008
MECTACER BIOLOX FORTE-FEMORAL HEADS
K073337
Medacta International S.A.
Orthopedic · 77d
Cleared Feb 06, 2008
DYNASTY CERAMIC FEMORAL HEAD
K072656
Wrightmedicaltechnologyinc
Orthopedic · 139d
Cleared Nov 27, 2007
BIOLOX DELTA CERAMIC HEADS WITH 100KGY E-POLY ACETABULAR LINERS
K073102
Biomet Manufacturing Corp
Orthopedic · 25d
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 Aug 01, 2007
CERAMIC BALL HEADS, 28, 32 AND 36 MM
K070928
Plus Orthopedics AG
Orthopedic · 120d
Cleared May 16, 2007
UNIVERSAL TAPER DELTA FEMORAL HEAD
K070885
Howmedica Osteonics Corp.
Orthopedic · 47d
Cleared Mar 15, 2007
EXACTECH NOVATION CROWN CUP AND LINERS
K070479
Exactech, Inc.
Orthopedic · 23d
Cleared Feb 02, 2007
PCA ALUMINA FEMORAL HEADS
K063816
Stryker Orthopaedics
Orthopedic · 42d
Cleared Dec 20, 2006
TRIDENT II ACETABULAR SYSTEM
K063616
Howmedica Osteonics Corp.
Orthopedic · 15d
Cleared Dec 08, 2006
ARCOMXL POLYETHYLENE LINERS AND 38/40MM FEMORAL HEADS
K062997
Biomet Manufacturing Corp
Orthopedic · 67d
Cleared Nov 30, 2006
MODIFICATION: TO DEPUY DELTA CERAMIC FEMORAL HEAD
K062748
DePuy Orthopaedics, Inc.
Orthopedic · 77d
Cleared Nov 29, 2006
NOVATION SPLINED RDD FEMORAL STEMS
K063279
Exactech, Inc.
Orthopedic · 29d
Cleared Nov 22, 2006
EXCIA TOTAL HIP SYSTEM 36MM CERAMIC HEAD
K062684
Aesculap, Inc.
Orthopedic · 75d
Cleared Sep 01, 2006
PORTLAND CERAMIC (BIOLOX-FORTE) FEMORAL HEAD
K061564
Portland Orthopaedics Pty. , Ltd.
Orthopedic · 88d
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 May 10, 2006
HIPSTAR FEMORAL STEM
K051223
Stryker Orthopaedics
Orthopedic · 363d
Cleared Apr 28, 2006
ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS
K060577
Ortho Development Corp.
Orthopedic · 53d