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
Cleared
Oct 30, 2015
MasterLoc Stem
Medacta International
Orthopedic
144d
Cleared
Sep 03, 2015
REDAPT¿ Revision Femoral System
Smith & Nephew, Inc.
Orthopedic
55d
Cleared
Jul 20, 2015
Exactech Alteon Monobloc Revision Stem
Exactech, Inc.
Orthopedic
188d
Cleared
Apr 20, 2015
POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA
Smith & Nephew, Inc.
Orthopedic
111d
Cleared
Apr 20, 2015
PROFEMUR Preserve Size 1-3 Hip Stems
Microport Orthopedics, Inc.
Orthopedic
89d
Cleared
Apr 10, 2015
PROFEMUR Preserve Classic Stem
Microport Orthopedics, Inc.
Orthopedic
63d
Cleared
Mar 24, 2015
SL-PLUS MIA and SL-PLUS Femoral Stems with Ti/HA
Smith & Nephew, Inc.
Orthopedic
147d
Cleared
Jan 27, 2015
MasterSL femoral stem
Lima Corporate S.P.A.
Orthopedic
47d
Cleared
Nov 06, 2014
LINK MP RECONSTRUCTION PROSTHESIS
Waldemar Link GmbH & Co. KG
Orthopedic
90d
Cleared
Sep 12, 2014
PROFEMUR RENAISSANCE CLASSIC LONG NECK HIP STEMS
Microport Orthopedics, Inc.
Orthopedic
122d
Cleared
Aug 28, 2014
ALTEON NECK PRESERVING FEMORAL STEM, STANDARD OFFSET, SIZE 6-7
Exactech, Inc.
Orthopedic
52d
Cleared
Aug 18, 2014
BIOLOX DELTA CERAMIC OPTION HEADS
Biomet, Inc.
Orthopedic
59d
Cleared
Aug 06, 2014
MINIMA S SYSTEM
Lima Corporate S.P.A.
Orthopedic
77d
Cleared
Jun 30, 2014
EXACTECH TAPERED WEDGE FEMORAL STEM
Exactech, Inc.
Orthopedic
104d
Cleared
Jun 10, 2014
MASTERSL FEMORAL STEM
Lima Corporate S.P.A.
Orthopedic
55d
Cleared
May 30, 2014
PROFEMUR TL CLASSIC LONG NECK HIP STEMS
Microport Orthopedics, Inc.
Orthopedic
73d
Cleared
Apr 03, 2014
DYNASTY SHELL, DYNASTY A-CLASS CROSSLINKED POLY LINER, BIOLOX DELTA FEMORAL HEAD
Microport Orthopedics, Inc.
Orthopedic
85d
Cleared
Dec 16, 2013
CORIN METAFIX HIP STEM
Corin USA
Orthopedic
172d
Cleared
Dec 16, 2013
CORIN MINIHIP STEM
Corin USA
Orthopedic
171d
Cleared
Nov 04, 2013
MECTACER BIOLOX OPTION HEADS
Medacta International
Orthopedic
160d
Cleared
Oct 22, 2013
SMITH & NEPHEW GLOBAL FEMORAL HEAD TRIALS
Smith & Nephew, Inc.
Orthopedic
78d
Cleared
Oct 10, 2013
POLARSTEM STANDARD AND LATERAL FEMORAL STEMS WITH TI/HA
Smith & Nephew, Inc.
Orthopedic
206d
Cleared
Oct 10, 2013
BIOLOX(R) DELTA CERAMIC HEADS
Biomet, Inc.
Orthopedic
122d
Cleared
Oct 01, 2013
MPACT DM LINER CONVERTER
Medacta International
Orthopedic
134d