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
169–192 of 531
Cleared Sep 12, 2014
PROFEMUR RENAISSANCE CLASSIC LONG NECK HIP STEMS
K141235
Microport Orthopedics, Inc.
Orthopedic · 122d
Cleared Aug 28, 2014
ALTEON NECK PRESERVING FEMORAL STEM, STANDARD OFFSET, SIZE 6-7
K141821
Exactech, Inc.
Orthopedic · 52d
Cleared Aug 18, 2014
BIOLOX DELTA CERAMIC OPTION HEADS
K141653
Biomet, Inc.
Orthopedic · 59d
Cleared Aug 06, 2014
MINIMA S SYSTEM
K141327
Lima Corporate S.P.A.
Orthopedic · 77d
Cleared Jul 21, 2014
EXCIA TOTAL HIP SYSTEM
K140915
Aesculap Implant Systems, LLC
Orthopedic · 102d
Cleared Jun 30, 2014
EXACTECH TAPERED WEDGE FEMORAL STEM
K140674
Exactech, Inc.
Orthopedic · 104d
Cleared Jun 10, 2014
MASTERSL FEMORAL STEM
K140975
Lima Corporate S.P.A.
Orthopedic · 55d
Cleared May 30, 2014
PROFEMUR TL CLASSIC LONG NECK HIP STEMS
K140676
Microport Orthopedics, Inc.
Orthopedic · 73d
Cleared Apr 03, 2014
DYNASTY SHELL, DYNASTY A-CLASS CROSSLINKED POLY LINER, BIOLOX DELTA FEMORAL HEAD
K140043
Microport Orthopedics, Inc.
Orthopedic · 85d
Cleared Mar 13, 2014
OMNI ARC MONOBLOCK HIP STEM
K133381
Omnilife Science
Orthopedic · 129d
Cleared Dec 16, 2013
CORIN METAFIX HIP STEM
K131952
Corin USA
Orthopedic · 172d
Cleared Dec 16, 2013
CORIN MINIHIP STEM
K131986
Corin USA
Orthopedic · 171d
Cleared Nov 04, 2013
MECTACER BIOLOX OPTION HEADS
K131518
Medacta International
Orthopedic · 160d
Cleared Oct 22, 2013
SMITH & NEPHEW GLOBAL FEMORAL HEAD TRIALS
K132435
Smith & Nephew, Inc.
Orthopedic · 78d
Cleared Oct 10, 2013
POLARSTEM STANDARD AND LATERAL FEMORAL STEMS WITH TI/HA
K130728
Smith & Nephew, Inc.
Orthopedic · 206d
Cleared Oct 10, 2013
BIOLOX(R) DELTA CERAMIC HEADS
K131684
Biomet, Inc.
Orthopedic · 122d
Cleared Oct 01, 2013
MPACT DM LINER CONVERTER
K131458
Medacta International
Orthopedic · 134d
Cleared Sep 27, 2013
TRINITY ACETABULAR SYSTEM
K131647
Corin USA
Orthopedic · 114d
Cleared Sep 03, 2013
U-MOTION II PS+ CUP
K132455
United Orthopedic Corp.
Orthopedic · 28d
Cleared Aug 22, 2013
AVENIR CEMENTED HIP STEM
K131884
Zimmer GmbH
Orthopedic · 58d
Cleared Jul 03, 2013
DYNASTY ACETABULAR SYSTEM WITH CERAMIC
K130376
Wrightmedicaltechnologyinc
Orthopedic · 139d
Cleared May 28, 2013
CORIN TRINITY ACETABULAR SYSTEM WITH EXTRA-LONG HEADS
K130343
Corin USA
Orthopedic · 106d
Cleared May 24, 2013
INTRABLOCK BIOBALL HIP SYSTEM (IBS)
K123619
Merete Medical GmbH
Orthopedic · 182d
Cleared May 24, 2013
CORIN METAFIX HIP STEM
K130634
Corin USA
Orthopedic · 74d