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..

531
Total
531
Cleared
144d
Avg days
1985
Since
531 devices
217–240 of 531
Cleared Jan 15, 2009
BIOLOX DELTA OPTION CERAMIC HEADS
K082996
Biomet, Inc.
Orthopedic · 99d
Cleared Dec 17, 2008
NOVATION 12/14 CEMENTED FEMORAL STEMS
K083392
Exactech, Inc.
Orthopedic · 30d
Cleared Nov 25, 2008
BIOLOX DELTA CERAMIC FEMORAL HEAD, BIOLOX DELTA CERAMIC FEMORAL HEAD OFFSET SLEEVE
K082844
Encore Medical, L.P.
Orthopedic · 60d
Cleared Oct 15, 2008
ENCORE HIP STEMS WITH CERAMIC HEADS AND UHMWPE LINERS
K082398
Encore Medical, L.P.
Orthopedic · 56d
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 Mar 13, 2008
BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM, MODEL 8777 SERIES
K073567
Zimmer GmbH
Orthopedic · 84d
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 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 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 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