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 Zimmer, Inc..

531
Total
531
Cleared
144d
Avg days
1985
Since
531 devices
217–240 of 531
Cleared Mar 19, 2012
METHA HIP SYSTEM
K112682
Aesculap Implant Systems, LLC
Orthopedic · 186d
Cleared Feb 17, 2012
WAGNER CONE PROSTHESIS SYSTEM
K113556
Zimmer GmbH
Orthopedic · 78d
Cleared Oct 07, 2011
MECTACER BIOLOX(R) DELTA FEMORAL HEADS
K112115
Medacta International
Orthopedic · 74d
Cleared Sep 23, 2011
UNITED 36MM CERAMIC FEMORAL HEAD, DELTA
K112463
United Orthopedic Corporation
Orthopedic · 28d
Cleared Sep 21, 2011
ORTHO DEVLOPMENT CERAMIC FEMORAL HEAD
K111936
Ortho Development
Orthopedic · 75d
Cleared Aug 29, 2011
NOVAE SUNFIT TH DUAL MOBILITY ACETABULAR CUP MODEL SUNFIT TH (METAL-BACK), NOVAE E TH DUAL MOBILITY ACETABULAR CUP MODEL
K111572
Serf
Orthopedic · 84d
Cleared Jun 29, 2011
CORIN MINIHIP FEMORAL STEM
K111046
Corin USA
Orthopedic · 75d
Cleared Jun 27, 2011
APEX ARC HIP STEM
K111193
Omni Life Science, Inc.
Orthopedic · 60d
Cleared May 03, 2011
CORIN TRINITY ACETBULAR SYSTEM WITH HXLPE LINERS
K110087
Corin USA
Orthopedic · 111d
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 28, 2011
CORIN BIOLOX DELTA FEMORAL HEADS
K103120
Corin USA
Orthopedic · 129d
Cleared Feb 11, 2011
VERSAFITCUP CC TRIO
K103352
Medacta International
Orthopedic · 87d
Cleared Feb 03, 2011
MODULAR DUAL MOBILITY LINER, X3 ACETABULAR INSERT
K103233
Howmedica Osteonics Corp.
Orthopedic · 93d
Cleared Dec 20, 2010
MEDACTA TOTAL HIP PROSTHESIS SYSTEM - AMISTEM C & QUADRA C SHORT NECK
K103189
Medacta International S.A.
Orthopedic · 53d
Cleared Nov 10, 2010
EXACTECH BIOLOXDELTA / BIOLOX FEMORAL HEADS, 28MM OD, 32MM OD, 36MM OD, EXACTECH BIOLOX OPTION ADAPTERS/FEMORAL HEADS
K103012
Exactech, Inc.
Orthopedic · 29d
Cleared Nov 08, 2010
NOVATION FEMORAL STEM, TAPERED 12/14 , STANDARD/EXTENDED OFFSET, PLASMA COATED, PRESS-FIT, SIZE 19/20
K102487
Exactech, Inc.
Orthopedic · 70d
Cleared Jul 30, 2010
ZIMMER SEGMENTAL SYSTEM PROXIMAL FEMORAL COMPONENT AND SMALL DIAMETER STEM EXTENSIONS
K101296
Zimmer, Inc.
Orthopedic · 81d
Cleared Jun 22, 2010
APEX MODULE HIP SYSTEM BIOLOX DELTA FEMORAL HEAD
K101451
Omni Life Science, Inc.
Orthopedic · 28d
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