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
241–264 of 534
Cleared May 18, 2010
CARDO MEDICAL CERAMIC HIP SYSTEM
K100008
Cardo Medical, Inc.
Orthopedic · 134d
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 Apr 07, 2010
APEX ARC HIP STEM
K090845
Omni Life Science, Inc.
Orthopedic · 376d
Cleared Apr 05, 2010
MINIHIP STEM
K083312
Corin USA
Orthopedic · 511d
Cleared Feb 04, 2010
CORIN METAFIX FEMORAL STEM
K082525
Corin USA
Orthopedic · 520d
Cleared Feb 04, 2010
LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS
K093846
Zimmer, Inc.
Orthopedic · 51d
Cleared Jan 21, 2010
MEDACTA TOTAL HIP PROTHESIS SYSTEM-AMISTEN H , QUADRA H, QUADRA S
K093944
Medacta International S.A.
Orthopedic · 30d
Cleared Dec 16, 2009
44MM E1 ACETABULAR LINER WITH 44MM BIOLOX DELTA OPTION CERAMIC HEAD OR 44MM M A MAGNUM
K093549
Biomet Manufacturing Corp
Orthopedic · 29d
Cleared Apr 24, 2009
BIOLOX OPTION CERAMIC FEMORAL HEAD AND METHA XL HEADS
K090299
Aesculap Implant Systems
Orthopedic · 77d
Cleared Mar 11, 2009
BIOLOX DELTA CERAMIC FEMORAL HEADS
K083762
Smith & Nephew, Inc.
Orthopedic · 83d
Cleared Mar 06, 2009
MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA C
K083558
Medacta International S.A.
Orthopedic · 94d
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 Jan 15, 2009
MODIFICATION TO: METHA HIP SYSTEM
K083495
Aesculap Implant Systems, Inc.
Orthopedic · 51d
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 Nov 20, 2008
BIOLOX DELTA CERAMIC FEMORAL HEAD
K082991
Aesculap Implant Systems, Inc.
Orthopedic · 44d
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 Aug 07, 2008
METHA SHORT STEM HIP SYSTEM
K081973
Aesculap Implant Systems, Inc.
Orthopedic · 28d
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